Respironics BiPAP Synchrony Provider Manual

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www.respironics.com

Provider Manual

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BiPAP systems are the subject of one or more of U.S. Patents #5148802, #5239995, #531937, #5433193, Canadian Patent #2, 024, 477, European Patent #EP0425092, German Patent #69021681.5-08, and other pending U.S. and foreign patents. BiPAP is a registered trademark of Respironics, Inc.

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Table of Contents

Chapter 1: Warnings and Cautions .......................................................................1-1

1.1 Warnings ..............................................................................................................................1-1

1.2 Cautions................................................................................................................................1-3

1.3 Intended Use.........................................................................................................................1-4

1.4 Contraindications ................................................................................................................1-4

1.5 Patient Precautions..............................................................................................................1-4

1.6 Communication Statements for Optional Modem ........................................................... 1-5

TYPES OF SERVICE............................................................................................................................................................ 1-5

TELEPHONE COMPANY PROCEDURES .................................................................................................................................. 1-5

IF PROBLEMS ARISE .......................................................................................................................................................... 1-5

1.7 Industry Canada Notice ......................................................................................................1-6

Chapter 2: Introduction..........................................................................................2-1

2.1 Synchrony Overview ...........................................................................................................2-1

2.2 Modes of Operation ............................................................................................................. 2-2

2.2.1 CPAP MODE ....................................................................................................................................................... 2-2

2.2.2 S MODE .............................................................................................................................................................. 2-2

2.2.3 S/T MODE ........................................................................................................................................................... 2-3

2.2.4 PRESSURE CONTROL MODE ................................................................................................................................... 2-3

2.2.5 TIMED MODE ....................................................................................................................................................... 2-3

2.2.6 MODE SUMMARY.................................................................................................................................................. 2-4

2.3 Digital Auto-T rak Sensitivity™ ..........................................................................................2-4

2.3.1 LEAK TOLERANCE ................................................................................................................................................ 2-4

2.3.2 SENSITIVITY ......................................................................................................................................................... 2-4

2.4 Access Levels ........................................................................................................................ 2-7

2.5 Symbol Key .......................................................................................................................... 2-8

2.6 Definitions, Acronyms, and Abbreviations ........................................................................ 2-9

2.7 Service...................................................................................................................................2-9

Chapter 3: Controls and Displays..........................................................................3-1

3.1 Control Panel .......................................................................................................................3-1

3.1.1 DISPLAY SCREEN .................................................................................................................................................. 3-1

3.1.2 CONTROL KEYS .................................................................................................................................................... 3-2

3.1.3 INDICATORS .......................................................................................................................................................... 3-2

3.2 Navigating the Screens ........................................................................................................3-5

3.3 Display Data .........................................................................................................................3-6

3.4 Patient Circuit Connection ................................................................................................. 3-7

3.5 Optional Oxygen Valve........................................................................................................3-7

3.6 Rear Panel ............................................................................................................................3-8

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Chapter 4: Setting up and Starting the Synchrony ..............................................4-1

4.1 Preparing the Synchrony ....................................................................................................4-1

4.1.1 SUMMARY OF SETUP OPERATIONS .......................................................................................................................... 4-1

4.1.2 INSTALLING THE AIR FILTERS................................................................................................................................. 4-2

4.1.3 ASSEMBLING THE PATIENT CIRCUIT ........................................................................................................................ 4-3

4.1.4 SUPPLYING POWER TO THE SYNCHRONY.................................................................................................................. 4-4

4.1.5 OPTIONAL INTERNAL MODEM ................................................................................................................................ 4-5

4.1.6 PERFORMANCE VERIFICATION ................................................................................................................................ 4-5

4.2 Setting Up the Synchrony ...................................................................................................4-5

4.3 Connecting the Patient ........................................................................................................4-5

4.4 Operating the System ..........................................................................................................4-6

4.5 Patient Operating Instructions...........................................................................................4-7

4.5.1 SETTING THE RISE TIME ........................................................................................................................................ 4-7

4.5.2 DIALING THE PROVIDER ........................................................................................................................................ 4-8

4.5.3 DATA TRANSMISSION ERRORS ................................................................................................................................ 4-9

4.5.4 USING THE RAMP FUNCTION ............................................................................................................................... 4-10

Chapter 5: Changing Parameters ..........................................................................5-1

5.1 Summary of Change Parameters Operations ................................................................... 5-1

5.2 Change Parameters Screens ............................................................................................... 5-2

5.2.1 CPAP MODE ....................................................................................................................................................... 5-2

5.2.2 S MODE .............................................................................................................................................................. 5-3

5.2.3 T , PC, AND S/T MODES ....................................................................................................................................... 5-3

5.3 Changing Synchrony Parameters ......................................................................................5-4

Chapter 6: Changing Modes...................................................................................6-1

6.1 Summary of Change Mode Operations ............................................................................. 6-1

6.2 Change Mode Setup Screens .............................................................................................. 6-2

6.2.1 CPAP MODE SETUP SCREEN................................................................................................................................. 6-2

6.2.2 S MODE SETUP SCREENS ...................................................................................................................................... 6-2

6.2.3 T , PC, AND S/T MODES SETUP SCREENS ............................................................................................................... 6-2

6.3 Changing the Synchrony Mode.......................................................................................... 6-3

Chapter 7: Options ..................................................................................................7-1

7.1 Summary of Options Operations .......................................................................................7-1

7.2 Synchrony Options Menu ................................................................................................... 7-2

7.2.1 TIME AT PRESSURE................................................................................................................................................ 7-2

7.2.2 SYSTEM CODES .................................................................................................................................................... 7-3

7.2.3 PATIENT ALARM HISTORY ..................................................................................................................................... 7-4

7.2.4 MODEM SETTINGS ................................................................................................................................................ 7-5

7.2.5 PEV SETTING ...................................................................................................................................................... 7-9

7.2.6 CHANGING THE ACCESS LEVEL ............................................................................................................................ 7-10

7.2.7 UNLOCKING THE ACCESS LEVEL .......................................................................................................................... 7-10

7.2.8 CHANGING THE LANGUAGE ................................................................................................................................. 7-11

7.2.9 CHANGING THE ALARM VOLUME ......................................................................................................................... 7-12

7.2.10 EXITING THE OPTIONS MENU .............................................................................................................................. 7-12

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Chapter 8: Alarms ...................................................................................................8-1

8.1 Alarm Introduction .............................................................................................................8-1

8.2 Setting Alarm Parameters...................................................................................................8-2

8.2.1 ALARM PARAMETER OPERATION SUMMARY ............................................................................................................ 8-2

8.2.2 CHANGING THE ALARM PARAMETERS ..................................................................................................................... 8-3

8.3 Summary of Alarm Behavior .............................................................................................8-6

8.3.1 ALARM SOUNDS BEHAVIOR ................................................................................................................................... 8-6

8.3.2 ALARM LED BEHAVIOR ....................................................................................................................................... 8-7

8.3.3 DISPLAY BEHAVIOR ............................................................................................................................................... 8-7

8.4 Summary of User Actions During Alarm ..........................................................................8-8

8.5 Alarm Tables ........................................................................................................................8-9

8.5.1 HIGH PRIORITY ALARMS ....................................................................................................................................... 8-9

8.5.2 MEDIUM PRIORITY ALARMS ................................................................................................................................ 8-10

8.5.3 LOW PRIORITY ALARMS ...................................................................................................................................... 8-11

8.5.4 ALARM DEFINITIONS ........................................................................................................................................... 8-12

Chapter 9: Communications...................................................................................9-1

9.1 Communicating via Optional Modem ...............................................................................9-1

9.2 Communicating with Encore Software..............................................................................9-1

iii

Chapter 10: Adding Supplemental Oxygen.........................................................10-1

10.1 Adding Supplemental Oxygen..........................................................................................10-1

10.2 Supplemental Oxygen Concentrations ............................................................................10-3

Chapter 11: Cleaning and Maintenance .............................................................. 11-1

11.1 Cleaning the Synchrony .................................................................................................... 11-1

11.2 Cleaning or Replacing the Inlet Filters............................................................................ 11-1

11.3 Maintenance ....................................................................................................................... 11-2

Chapter 12: Circuits and Accessories...................................................................12-1

12.1 Circuit Configurations ...................................................................................................... 12-1

12.2 Circuits and Accessories....................................................................................................12-2

12.3 Masks, Exhalation Ports, and Related Accessories ........................................................ 12-2

12.4 Humidifiers ........................................................................................................................12-2

12.5 Software..............................................................................................................................12-2

Chapter 13: Operational V erification...................................................................13-1

13.1 S Mode Verification ...........................................................................................................13-1

13.2 S/T Mode Verification .......................................................................................................13-2

13.3 Alarm Verification ............................................................................................................. 13.3

Chapter 14: Speciﬁcations ....................................................................................14-1

Appendix A: External Modem Requirements...................................................... A-1

A.1 Serial Cable ......................................................................................................................... A-1

A.2 Modem Commands ............................................................................................................ A-1

A.3 Example Initialization Strings........................................................................................... A-2

Appendix B: Error Codes ...................................................................................... B-1

Index ......................................................................................................................... I-1

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Package Contents

• BiPAP Synchrony

• power cord

• flexible tubing (1.8 m x 2 mm I.D.)

• filter cap

• pollen filters

• ultra-fine filter

• optional modem cable (4.27 m)

• User Guide*

BiPAP Synchrony

Filter Cap

Ultra-fine Filter

Pollen Filters

User Guide

User Guide*

www.respironics.com

Power Cord

Flexible Tubing

Optional Modem

Cable

* Not included with all models.

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Chapter 1: Warnings and Cautions

WARNING: Indicates the possibility of injury to the patient or the operator.

CAUTION: Indicates the possibility of damage to the device. CAUTION! US federal law restricts this device to sale by or on the order of a physician.

NOTE: Places emphasis on an operating characteristic.

1-1

1.1 Warnings

• This manual serves as a reference. The instructions in this manual are not intended to supersede the health care professional’s instructions regarding the use of the Synchrony.

• The operator should read and understand this entire manual before using the Synchrony.

• The Synchrony provides positive pressure ventilation and is indicated for assisted ventilation. The Synchrony does not provide ventilation with guaranteed tidal volume delivery. Patients requiring ventilation at predetermined tidal volumes are not candidates for pressure support ventilation.

• The Synchrony should be used only with masks and connectors recommended by Respironics or with those recommended by the health care professional or respiratory therapist. See Chapter 12 for approved patient circuits. A mask should not be used unless the Synchrony is turned on and operating properly. The exhalation port(s) associated with the mask should never be blocked.

Explanation of the Warning: The Synchrony is intended to be used with special masks or connectors that have exhalation ports to allow continuous flow of air out of the mask. When the Synchrony is turned on and functioning properly, new air from the Synchrony flushes the exhaled air out through the mask exhalation port. However, when the Synchrony is not operating, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation.

• In the event of a power or device failure, audible and visual alarm signals will activate. The Synchrony must be disconnected from the patient immediately. As is the case with most ventilators with passive exhalation ports, when power is lost, sufficient air will not be provided through the circuit and exhaled air may be rebreathed.

• At low EPAP pressures, the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing. Some rebreathing may occur.

• If supplemental oxygen is added to the breathing circuit, the optional oxygen valve must be installed and used as shown in Chapter 10. The valve automatically stops the flow of oxygen when the blower is off.

• If oxygen is used with the Synchrony, the oxygen flow must be turned off when the Synchrony is not operating.

Explanation of the Warning: When the Synchrony is not in operation, and the oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate within the Synchrony’s enclosure. Oxygen accumulated in the ventilator enclosure will create a risk of fire.

• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open ﬂame.

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1-2

W arnings (continued)

• When administering fixed-flow supplemental oxygen, the oxygen concentration may not be constant. The inspired oxygen concentration will vary, depending on the IPAP and EPAP settings, patient breathing pattern, and the leak rate. Substantial leaks around the mask may reduce the inspired oxygen concentration to less than the expected concentrations shown in Chapter 10. Appropriate patient monitoring should be used.

• Operation of the Synchrony may be adversely affected by —electromagnetic fields exceeding the level of 10 V/m in the test

conditions of EN 60601-1-2 —the operation of high frequency (diathermy) equipment —defibrillators, or short wave therapy equipment —radiation (e.g., x-ray, CT) —magnetic fields (e.g., MRI).

• The Synchrony is not suitable for use in the presence of ﬂammable mixtures such as gases, anesthetics and liquids.

• Do not use the Synchrony at room temperatures above 35°C. If the Synchrony is used at room temperatures above 35°C, the temperature of the airflow may exceed 41°C, which could cause thermal irritation or injury to the patient’s airway.

• Do not operate the Synchrony in direct sunlight or near a heating appliance because these conditions can increase the temperature of the airflow delivered to the patient.

• To reduce the risk of contamination, a low resistance main ﬂow bacteria ﬁlter may be placed in-line between the Synchrony and the patient.

• The Synchrony does not have an alarm to detect occlusion of the exhalation port. Before each use, inspect the patient circuit to verify that the port is not occluded. Occlusion or partial occlusion can reduce airflow and result in rebreathing of exhaled air.

• Do not use antistatic or electrically conductive hoses or tubing with the Synchrony.

• When the Synchrony is used with a humidiﬁer, position the humidifier such that the water level in the humidifier is lower than the patient, and the humidifier is on the same level or lower than the Synchrony.

• If you detect any unexplained changes in the performance of the Synchrony, if the Synchrony is dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, seek the assistance of Respironics or an authorized service center.

• Repairs and adjustments must be performed by Respironics or an authorized service center. Service done by inexperienced or unqualiﬁed personnel, or installation of unauthorized parts could cause injury, invalidate the warranty, or result in costly damage.

• Electrical cords and cables should be periodically inspected for damage or signs of wear.

• To avoid electrical shock, unplug the Synchrony before cleaning it.

• Verify the operation of the patient disconnect alarm with any changes in the patient circuit.

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1-3

Warnings (continued)

1.2 Cautions

• Verify that the Patient Disconnect alarm is active if required for

medical reasons.

• The Synchrony may only be operated at temperatures between 5°C and

35°C.

• Do not immerse the Synchrony or allow any liquid to enter the

enclosure or the inlet ﬁlter.

• Condensation may damage the Synchrony. Always allow the

Synchrony to reach ambient temperature before use.

• Use the AC cable retainer to keep the AC power cord from falling out.

Additional Warnings, Cautions, and Notes are located throughout this manual.

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1-4

1.3 Intended Use

WARNING! Do not connect any equipment to the Synchrony unless recommended by Respironics or the health care

professional. Verify that an exhalation port is present to exhaust CO2 from the circuit. If circuit accessories other than those recommended by Respironics are connected to the Synchrony, then pressures must be verified. Use of these accessories may alter the pressure received, reducing the effectiveness of treatment.

1.4 Contraindications

The Synchrony is intended to provide noninvasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony may be used in the hospital or home.

The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.

The use of the Synchrony is contraindicated on patients without a spontaneous respiratory drive.

The use of the Synchrony for noninvasive positive pressure therapy may be contraindicated on patients

• unable to maintain a patent airway or adequately clear secretions,

• at risk for aspiration of gastric contents,

• with acute sinusitis or otitis media,

• with a history of allergy or hypersensitivity to the mask materials where the risk from allergic reaction outweighs the beneﬁt of ventilatory assistance,

• with epistaxis, causing pulmonary aspiration of blood, or

• with hypotension.

NOTE: When assessing the relative risks and benefits, the health care professional should understand that the

Synchrony can be set to deliver pressures up to 30 cm H2O. Also, in the unlikely event of certain fault conditions, a maximum static pressure of 40 cm H2O is possible.

1.5 Patient Precautions

• Advise the patient to immediately report any unusual chest discomfort, shortness of breath, or severe headache.

• If skin irritation or breakdown develops from the use of the mask, refer to the mask instructions for appropriate action.

• The following are potential side effects of noninvasive positive pressure therapy:

—ear discomfort

—conjunctivitis —skin abrasions due to noninvasive interfaces —gastric distention (aerophagia).

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1.6 Communication Statements for Optional Modem

NOTE: An optional internal modem is available in models of the Synchrony sold in the United States and

Canada. If your model does not have this feature, you can connect the Synchrony to an external modem. The following statements apply to use of the Synchrony with a modem through U.S. telephone lines.

1-5

TYPES OF SERVICE

TELEPHONE COMPANY

PROCEDURES

IF PROBLEMS ARISE

The Synchrony optional internal modem is designed to be used on standard device telephone lines. It connects to the telephone line by means of a standard jack called the USOC RJ-11C (or USOC FJ45S). Connection to telephonecompany-provided coin service (central office implemented systems) is prohibited. Connection to party lines service is subject to state tariffs.

The goal of the telephone company is to provide you with the best service it can. In order to do this, it may occasionally be necessary for them to make changes in their equipment, operations or procedures. If these changes might affect your service or the operation of your equipment, the telephone company will give you notice, in writing, to allow you to make any changes necessary to maintain uninterrupted service. In certain circumstances, it may be necessary for the telephone company to request information from you concerning the equipment that you have connected to your telephone line. Upon request of the telephone company, provide the FCC registration number and the ringer equivalence number (REN); both of these items are listed on the equipment label. The sum of all the RENs on your telephone lines should be less than five in order to assure proper service from the telephone company. In some cases, a sum of five may not be usable on a given line.

If any of your telephone equipment is not operating properly, you should immediately remove it from your telephone line, as it may cause harm to the telephone network. If the telephone company notes a problem, they may temporarily discontinue service. When practical they will notify you in advance of the disconnection. If advance notice is not feasible, you will be notified as soon as possible. When you are notified, you will be given the opportunity to correct the problem and informed of your right to file a complaint with the FCC. Contact your telephone company if you have questions about your phone line. In the event repairs are ever needed on the Synchrony, they should be performed by Respironics or an authorized representative of Respironics. For information contact Respironics. (See page 2-9.)

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1-6

1.7 Industry Canada Notice

NOTICE: The Industry Canada Label identifies certified equipment. This certification means that the equipment meets

telecommunications network protective, operational, and safety requirements as prescribed in the appropriate Terminal Equipment Technical Requirements documents. The Department does not guarantee the equipment will operate to the user’s satisfaction.

Before installing this equipment, users should make sure that it is permissible to be connected to the facilities of the local telecommunications company. The equipment must also be installed using an acceptable method of connection. The customer should be aware that compliance with the above conditions may not prevent degradation of service in some situations.

Repairs to certified equipment should be coordinated by a representative designated by the supplier. Any repairs or alterations made by the user to this equipment, or equipment malfunctions, may give the telecommunications company cause to request the user to disconnect the equipment.

Users should ensure for their own protection that the electrical ground connections of the power utility, telephone lines and internal metallic water pipe system, if present, are connected together. The precaution may be particularly important in rural areas.

CAUTION: Users should not attempt to make such connections themselves, but should contact the appropriate electric inspection authority, or electrician, as appropriate.

Ringer Equivalence Number (REN): The REN assigned to each terminal device provides an indication of the maximum number of terminals allowed to be connected to a telephone interface. The termination on an interface may consist of any combination of devices subject only to the requirement that the sum of the Ringer Equivalence Numbers of all the devices does not exceed 5.

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Chapter 2: Introduction

2.1 Synchrony Overview

WARNING: The Synchrony can operate on AC or DC power. The DC power option is not intended as a battery

backup during use of AC power.

CAUTION: When DC power is obtained from a vehicle battery, the Synchrony should not be used while the

engine of the vehicle is running. Damage to the vehicle may occur.

NOTE: The Synchrony is available in two models. The BiPAP Synchrony Lab System is for use by

clinicians in a sleep lab setting. The BiPAP Synchrony Ventilatory Support System is for use in a hospital or home setting. Throughout this manual, references to “Synchrony” will apply to both the Lab System and the Ventilatory Support System unless otherwise noted.

NOTE: Throughout this manual, references to Bi-Flex apply only to the Synchrony Lab System.

The Synchrony, shown in Figure 2-1, is a low-pressure, electrically driven ventilator system with electronic pressure control. The Synchrony’s pressure controls are adjusted to deliver pressure support for patient ventilatory

Figure 2-1 Synchrony

assistance.

The Synchrony is intended to augment patient breathing by supplying pressurized air through a patient circuit. It senses the patient’s breathing effort by monitoring airflow in the patient circuit and adjusts its output to assist in inhalation and exhalation. This assistance is provided by the administration of two levels of positive pressure. During exhalation, pressure is variably positive or near ambient. During inspiration, pressure is variably positive and always higher than the expiratory level.

2-1

The Synchrony responds reliably to patient flow rates that indicate movement to inhalation or exhalation, even in the presence of most normal leaks in the patient circuit. Automatic adjustment of this trigger threshold in the presence of leaks makes the system ideal for mask-applied ventilation assistance. The patient-controllable Rise Time may enhance patient-ventilator synchrony and patient comfort.

If the patient interface is disconnected, the Synchrony automatically reduces the output flow to a low level. When the interface is replaced, therapy will typically resume when the patient starts to breathe. If therapy does not resume when the patient starts to breathe, the patient should press the RAMP/ALARM SILENCE button to resume therapy.

A modem allows the patient to provide compliance data to the home care provider with a few simple key presses. A communications port provides communication to the Respironics Encore® or Encore Pro Data Management Software.

The Synchrony operates in the following modes:

• Continuous Positive Airway Pressure (CPAP)

• Spontaneous (S)

• Spontaneous/Timed (S/T)

• Timed (T)

• Pressure Control (PC).

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2-2

2.2 Modes of Operation

2.2.1 CPAP MODE

2.2.2 S MODE

In the Continuous Positive Airway Pressure (CPAP) mode, the Synchrony delivers a continuous pressure support ventilation at one pressure level.

The Spontaneous (S) mode of the Synchrony delivers bi-level pressure support. The unit triggers to Inspiratory Positive Airway Pressure (IPAP) in response to spontaneous inspiratory effort and cycles to Expiratory Positive Airway Pressure (EPAP) during exhalation. Figure 2-2 illustrates the trigger and cycle concepts.

Cycle

Inspiration

Trigger

Expiration

IPAP

EPAP

Rise Time

Inspiratory Time

Figure 2-2 Triggering and Cycling in S Mode

The level of pressure support (PS) delivered is determined by the difference between the IPAP and EPAP settings (PS = IPAP - EPAP).

Bi-Flex

The Synchrony Lab System provides the Bi-Flex feature in S mode. The BiFlex attribute adjusts therapy by inserting a small amount of pressure relief during the latter stages of inspiration and during active exhalation (the beginning part of exhalation). In the following diagram, the bold lines represent Bi-Flex in comparison to the dashed line representing normal BiPAP therapy. Bi-Flex levels of 1, 2, or 3 progressively reflect increased pressure relief that will take place at the end of inspiration and at the beginning of expiration.

IPAP

EPAP

Bi-Flex

BiPAP

1 2

Time

Figure 2-3 Bi-Flex in Comparison to Traditional Bi-level Therapy

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2-3

2.2.3 S/T MODE

The Spontaneous/Timed (S/T) mode of the Synchrony is similar to the S mode, except that it also can deliver a machine-triggered breath if the patient does not spontaneously breath within a set time.

The S/T mode ensures that patients will receive a minimum number of breaths per minute based on the Rate setting. If the patient fails to initiate an inspiration within the interval determined by the Rate control, the unit triggers a timed (or machine-triggered) breath resulting in a pressure-control (pressure-limited, time-cycled) breath at the set IPAP level. The rate of timed breaths is adjustable. The duration of each timed breath is controlled by an Inspiratory Time control. See Figure 2-4 for an example of patient-triggered and machinetriggered breaths.

Example:

IPAP = 14 cm H2O EPAP = 6 cm H2O Rate = 10 BPM PS = 8 cm H2O

Time Interval

Exceeds Rate Setting

(approx. 6 sec)

(cm H2O)

11 1

Vol

(ml)

11 2

2.2.4 PRESSURE CONTROL MODE

2.2.5 TIMED MODE

1 = Spontaneously-triggered pressure support breaths. 2 = Time-triggered, pressure-limited, time-cycled breath.

Figure 2-4 Example of Patient-Triggered and Machine-Triggered Breaths

The Pressure Control (PC) mode is similar to the S/T mode, except that all breaths are machine-cycled. The PC mode is a pressure-limited, machine- or patient-triggered, time-cycled mode. Therefore, the inspiratory pressure may be triggered by the patient or by the Synchrony, but IPAP will be pressure-limited with a set cycle time determined by the Inspiratory Time control.

The Timed (T) mode provides mandatory pressure assist with bi-level pressures. All breaths are machine-triggered and machine-cycled; the patient’s breathing rate has no effect on the machine rate or pressure levels. The trigger to IPAP is determined by the Rate control, and the cycle time is determined by the Inspiratory Time control.

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2-4

2.2.6 MODE SUMMARY

2.3 Digital Auto-T rak Sensitivity™

2.3.1 LEAK TOLERANCE

Table 2-1 summarizes the initiation of triggers and cycles for each bi-level mode.

Mode Trigger Limit Cycle

S Patient Pressure Patient or Device S/T Patient or Machine Pressure Patient or Device PC Patient or Machine Pressure Device T Machine Pressure Device

Table 2-1 Initiation of Triggers and Cycles for Synchrony Modes

An important characteristic of the Synchrony is its ability to recognize and compensate for unintentional leaks in the system and to automatically adjust its trigger and cycle algorithms to maintain optimum performance in the presence of leaks. This feature is known as Digital Auto-Trak Sensitivity. The following sections examine this function in detail by describing the leak tolerance function and sensitivity.

A microprocessor monitors the total flow of the patient circuit and calculates patient flow values.

2.3.2 SENSITIVITY

1. Leak Estimation—Average and Parabolic

The Synchrony uses two leak estimation algorithms. A conservation of mass algorithm is used to compute the average leak for a given pressure support relationship. This average leak is used when large leak variations are present in the system. Average leak is a high estimate during EPAP pressure and a low estimate during IPAP pressure.

A better leak estimate, enabled by the digital system, is the parabolic leak algorithm. Parabolic leak is proportional to the square of the patient pressure; therefore, the leak estimate is correlated to the changing patient pressure. Both algorithms include unintentional circuit leak and are averaged over several breaths.

2. Patient Flow

The total circuit flow is comprised of the circuit leak and the patient flow. The calculated patient flow is the total flow minus the circuit leak. Patient flow is a primary input into the triggering and cycling mechanisms.

An essential feature of the Synchrony while operating in the S, S/T, and PC modes is its ability to effectively sense spontaneous breathing efforts, which causes the ventilator to trigger to IPAP and cycle to EPAP. Because no preset sensitivity threshold can assure patient and machine synchrony with changing breathing efforts and circuit leaks, the Synchrony continuously tracks patient breathing patterns and automatically adjusts sensitivity thresholds to ensure optimum sensitivity as breathing patterns change or as circuit leaks change. The algorithms used to ensure optimum sensitivity are the Volume Trigger, Shape Signal, and the Spontaneous Expiratory Threshold (SET).

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2-5

Volume Trigger (EPAP to IPAP)

Shape Trigger/Shape Cycle (EPAP to IPAP) (IPAP to EPAP)

The volume trigger is one method used to trigger IPAP during spontaneous breathing in the S, S/T, and PC modes. The volume trigger threshold is 6 cc of accumulated patient inspiratory volume. When patient effort generates inspiratory ﬂow causing 6 cc of volume, IPAP is triggered.

The shape trigger/cycle is another method used to trigger IPAP and/or cycle from IPAP to EPAP during spontaneous breathing in the S, S/T, and PC modes. This method continuously tracks patient inspiratory and expiratory ﬂow and adjusts the spontaneous trigger and cycle thresholds for optimum sensitivity. The Shape Signal appears as a shadow image of the patient’s actual ﬂow. The shape signal functions as a sensitivity threshold at either inspiration or expiration. When the patient’s ﬂow rate crosses the shape signal the unit changes pressure levels. Figure 2-5 illustrates how the shape signal is superimposed onto the actual waveform to trigger and cycle off IPAP.

The shape signal is created by offsetting the signal from the actual patient ﬂow by 15 L/min and delaying it for a 300 msec period. This intentional delay causes the shape signal to be slightly behind the patient’s ﬂow rate. A sudden change in patient ﬂow will cross the shape signal, causing the pressure level to change.

IPAP

PRESSURE

EPAP

Cycle to

EPAP

Crossover

Point

Trigger to

IPAP

Crossover

Point

FLOW

Shape Signal

Estimated

Patient

Flow

Figure 2-5 Shape Signal

Tracking the patient’s ﬂow pattern with the Shape Signal provides a sensitive mechanism to trigger to IPAP or cycle to EPAP in response to changing breathing patterns and circuit leaks.

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2-6

Spontaneous Expiratory Threshold (IPAP to EPAP)

A second method used to cycle off IPAP during spontaneous breathing in the S, S/T, and PC modes is called Spontaneous Expiratory Threshold (SET). The SET rises in proportion to the inspiratory ﬂow rate on each breath. When the Spontaneous Expiratory Threshold (SET) and actual patient ﬂow value are equal, the unit cycles to EPAP.

IPAP

PRESSURE

EPAP

Spontaneous Expiratory Threshold

FLOW

Maximum IPAP Time (IPAP to EPAP)

Flow Reversal (IPAP to EPAP)

Summary

Figure 2-5 Spontaneous Expiratory Threshold

A maximum IPAP time of 3.0 seconds acts as a safety mechanism to limit the time spent at the IPAP level during spontaneous breathing in the S, S/T, and PC modes. Once the time limit is reached, the unit automatically cycles off IPAP to the EPAP level.

As flow begins to decrease during IPAP, a flow reversal can occur due to a large leak around the mask or because the patient’s mouth is open. When the Synchrony unit senses this flow reversal, the unit automatically cycles to the EPAP level.

The sensitivity criteria for spontaneous breathing in the S, S/T, and PC modes can be summarized as follows:

Spontaneous Trigger to IPAP

A transition from EPAP to IPAP will occur when one of the following conditions is met:

• Patient ﬂow exceeds the shape signal

• 6 cc inspired patient volume

Cycle to EPAP

The transition from IPAP to EPAP will occur when one of the following conditions is met:

• Patient ﬂow is less than the shape signal

• Spontaneous Expiratory Threshold (SET) is achieved

• A 3.0 second maximum IPAP time has occurred (safety feature)

• Flow reversal occurs during IPAP (safety feature)

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2-7

2.4 Access Levels

The Synchrony can be set to a Lockout mode so that certain settings and displays cannot be accessed. In the Lockout mode, the IPAP Rise Time can be adjusted if Bi-Flex is not enabled. If Bi-Flex is enabled, then it is adjustable in Lockout Mode. Rise Time cannot be adjusted in Lockout mode when Bi-Flex is enabled. Only the IPAP, EPAP, and Respiratory Rate are displayed in Lockout Mode.

In the Full Access level, all ventilator functions and displays are accessible.

Section 7.2.6 describes the procedure to set the access level.

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2-8

2.5 Symbol Key

Symbol Meaning

The following symbols are used on the Synchrony:

AC Power Indicator

DC Power Indicator

Alarm Indicator

Type BF Applied Part

Class II for Protection Against Electric Shock

Attention, consult accompanying documents

Standby Key (Start/Stop)

Up Key

Down Key

Enter Key

Ramp Start/Alarm Silence Key

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2.6 Definitions, Acronyms, and Abbreviations

The following terms are used in this manual:

Bi-Flex—A therapy feature that establishes a level of pressure relief taking place at the end of inhalation and at the start of exhalation.

BiPAP—Bi-level Positive Airway Pressure

CPAP—Continuous Positive Airway Pressure

Cycle—The transition from inspiration to expiration

EPAP—Expiratory Positive Airway Pressure

High Priority Alarm—Alarm signal indicating a condition that requires immediate attention

IPAP—Inspiratory Positive Airway Pressure

Low Priority Alarm—Signal indicating an information message

2-9

2.7 Service

Medium Priority Alarm—Alarm signal indicating a condition that requires operator awareness

OSA—Obstructive Sleep Apnea

Ramp—A feature that may increase patient comfort when therapy is started. The Synchrony IPAP starts at the EPAP level and is increased gradually (breath by breath over several breaths) until the IPAP prescription pressure is reached.

RR—Respiratory Rate

Trigger—The transition from expiration to inspiration

If you need product support, call Respironics’ Customer Service Department: 1-800-345-6443 (USA or Canada only) or 1-724-387-4000.

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2-10

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Chapter 3: Controls and Displays

This chapter describes the control panel and displays, the patient circuit connections, and the rear panel connections.

3.1 Control Panel

Display

Screen

AC Power

Indicator

DC Power

Indicator

3-1

Red

Alarm Indicator

Yellow

Alarm Indicator

3.1.1 DISPLAY SCREEN

Down

Key

Standby

Key

Figure 3-1 The Synchrony Control Panel

Figure 3-1 illustrates the Synchrony control panel. The control panel includes:

• display screen

• control keys

• alarm indicators

• power indicators.

The display screen is used to display operating parameters, instructions, and messages. A backlight is activated when the , , or key is pressed, and remains on until there are no keystrokes for one minute. If the backlight is off, the first press of any of these keys will only turn the backlight on; the normal key action is suppressed until the key is pressed a second time.

Ramp/

Alarm Silence

Key

Enter

Key

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3-2

3.1.2 CONTROL KEYS

Standby Key

Down Key

Enter Key

Ramp/Silence Key

3.1.3 INDICATORS

Up Key

The Synchrony control panel has five membrane-type switches that perform different functions depending on the screen selected, alarm status, and access level:

Starts and stops the Synchrony. The key must be pressed and released.

Navigates between screens or increases the value of a selected parameter by one increment.

Navigates between screens or decreases the value of a selected parameter by one increment.

Switches the function of the Up and Down keys between screen navigation and parameter adjustment, and implements changes.

Activates ventilation ramp and silences the audible alarm signal.

The Synchrony uses four LED indicators on the control panel for alarm indications and power indications. It also uses five indicators on the display screen.

AC Power Indicator

DC Power Indicator

Green LED that illuminates when the Synchrony is connected to AC power. See Figure 3-2.

Green

Figure 3-2 AC Power Indicator

Green LED that illuminates when the Synchrony is connected to DC power. See Figure 3-3.

Green

Figure 3-3 DC Power Indicator

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3-3

Red Alarm Indicator

Yellow Alarm Indicator

Attention or Activity Indicator ( )

• When flashing indicates a new high priority alarm has occurred.

• When on continuously indicates a loss of power or silenced high priority alarm.

• When flashing indicates a new medium priority alarm.

• When on continuously indicates a low priority alarm or silenced medium priority alarm.

Red

Yellow

Figure 3-4 Alarm Indicators

Used in several screens to indicate pressure level, machine-triggered breaths, or alarm messages:

• When appears next to EPAP or IPAP on the display, it indicates the current pressure phase. See Figure 3-5.

• When appears next to an alarm message, it indicates that the alarm is active. See Figure 3-6.

• When appears next to RR on the display, it indicates that the current pressure phase was device-triggered. See Figure 3-7.

MODE: S 1/2 IPAP 15 cm H2O EPAP 9 cm H2O RR 20 BPM

Figure 3-5 EPAP Indicator

ALARM: 1/1 Patient Disconnect

Figure 3-6 Alarm Indicator

MODE: S/T 1/4 IPAP 15 cm H2O EPAP 9 cm H2O RR 20 BPM

Figure 3-7 Device-Triggered Breath

Indicator

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3-4

Selection Indicator ( )

Navigation Indicator ( )

appears next to the item that can be selected with the ENTER key, as shown

in Figure 3-8. The indicator is moved by pressing the UP or DOWN key.

S PARAMETERS: 1/2 IPAP 15 cm H2O EPAP 9 cm H2O Rise Time 3

Figure 3-8 Selection Indicator; Pressing

the ENTER Key will Select EPAP for

Adjustment

appears next to a page number display to indicate that the UP and DOWN

keys can be used to change pages, as shown in Figure 3-9. If it appears next to a value, it flashes and indicates that the UP and DOWN keys can be used to adjust the value, as shown in Figure 3-10.

MODE: S 1/2 IPAP 15 cm H2O EPAP 9 cm H2O RR 20 BPM

Ventilation Ramp Indicator ( )

Figure 3-9 Page Indicator

S PARAMETERS: 1/2 IPAP 15 cm H2O EPAP 9 cm H2O Rise Time 3

Figure 3-10 Value Adjust Indicator; IPAP

can be adjusted with the UP or DOWN key

appears at the top of the display when ventilation ramp has been initiated.

See Figure 3-11.

MODE: S 1/2 IPAP 15 cm H2O EPAP 9 cm H2O RR 20 BPM

Figure 3-11 Ventilation Ramp Indicator

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3-5

Progress Indicator ( )

Alarm Enabled Indicator (A)

The consists of seven segments that empty from top to bottom to indicate the progress of certain operations. See Figure 3-12. The four indicators work simultaneously.

SYSTEM SELF TEST VER:X.XX XXXXX.X HRS XXX XXX XXX XXX XXX XXX XXX XXX XXX XXX

Figure 3-12 Progress Indicators

The A appears in the Monitoring screen if any of the patient alarms (Patient Disconnect, Apnea, or Low Minute Ventilation) is enabled (see Chapter 8).

Indicates a Patient

Alarm is Enabled

MODE: S/T 1/4 IPAP 15 cm H2O EPAP 9 cm H2O RR 20 BPM

3.2 Navigating the Screens

Figure 3-13 Monitoring Screen with

Alarm Enabled Indicator

When the screen indicates that there are multiple pages (1/3, 2/4, etc. appear in the upper right corner), you can scroll through the pages by pressing either the DOWN arrow key when the last item on the screen is selected, or by pressing the UP arrow key when the first item is selected.

Total Number

Page

Indicator

NEW MODE: S/T 2/3 Timed Insp 1.0 sec Rise Time 3

Figure 3-14 Example of Page Indicator on Screen

of Pages

In the example of Figure 3-14, if you press the UP key, the Synchrony displays page 1 of 3; if you press the DOWN key twice, the Synchrony displays page 3 of 3.

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3-6

3.3 Display Data

NOTE: The Estimated Exhaled Tidal

Volume and the Estimated Exhaled Minute Ventilation displays represent estimates. There are some circumstances, such as low tidal volumes, erratic breathing, or rapidly changing leak where the accuracy of the estimates will vary greatly. The Estimated Exhaled Tidal Volume and the Estimated Exhaled Minute Ventilation displays will flash during some transient conditions.

The display screen is used to display measured parameters in the Monitoring screens. The data changes depending on the access level and the mode of operation.

The Synchrony is capable of displaying:

• CPAP, IPAP, and EPAP - These displays are estimates of measure-

ments at the patient connection. Displays are updated as follows: CPAP is updated at the end of inspiration; IPAP is updated at the end of IPAP; and EPAP is updated at the end of EPAP.

• RR (Respiratory Rate) - The breathing rate is a running average from

the six previous breaths. If the Synchrony is operating in a mode that supports machine-triggered breaths, this display will be the total breathing rate (spontaneous + machine). The display value is updated at the end of each expiration.

• VTE (Estimated Exhaled Tidal Volume) - Displays an estimated

exhaled tidal volume measurement for the previous breath. The display is updated at the end of each breath. The estimated exhaled tidal volume is obtained by integration of patient flow.

• MinVent (Estimated Exhaled Minute Ventilation) - Displays the

estimated exhaled minute ventilation based on an average of the previous six breaths. The display is updated at the end of each breath.

• Leak - Displays the average leak value calculated during the previous

breath cycle. The display value is updated after each breath.

Table 3-1 summarizes the displayed parameters.

Parameter ModeUnits

CPAP IPAP EPAP

MinVent

Leak

Different display screens are available based on the access level:

Full Access—

Screen 1/4 Monitoring Screen Page 1 Screen 2/4 Monitoring Screen Page 2 Screen 3/4 Patient Controls Screen 4/4 Caregiver Menu

Lockout—

Screen 1/2 Monitoring Screen Page 1 Screen 2/2 Patient Controls

cm H2O cm H2O cm H2O

BPM

ml L/min L/min

Table 3-1 Displayed Parameters

Access Level

BOTH BOTH BOTH BOTH

FULL FULL FULL

CPAP S, T, PC, S/T S, T, PC, S/T

ALL ALL ALL ALL

See Section 4.4 for illustrations of these screens.

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3-7

3.4 Patient Circuit Connection

The patient circuit is connected to the patient interface port shown in Figure 3-15. The patient interface port accepts a bacteria filter or a tubing connector for reusable or disposable tubing.

Patient

Interface

Port

Oxygen

Valve

(Optional)

3.5 Optional Oxygen Valve

Figure 3-15 Synchrony Patient Interface Port and

Optional Oxygen Valve

The Synchrony optional oxygen valve is mounted under one side of the Synchrony, as shown in Figure 3-15. The valve must be used if oxygen is to be titrated into the breathing circuit. See Chapter 10 for instructions.

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3-8

3.6 Rear Panel

Figure 3-16 shows the rear panel of the Synchrony.

Telephone

Communications

Connector

DC Cord Retainer

(optional internal

modem only)

Inlet

Cord

Retainer

Jack

Inlet

Filter &

Filter Cap

Figure 3-16 The Synchrony Rear Panel

The rear panel contains

• the AC inlet that accepts the AC power cord

• the DC inlet that accepts the DC power cord

• the filter cap that is removed to inspect the inlet air filters (see Chapter

11)

• the RS-232 communications connector that accepts the Respironics Communications Cable for computer and external modem communication

• the RJ-11 telephone jack, provided with Synchrony devices having an optional internal modem, for remote data readings

• the DC power cord retainer that provides strain relief for the DC power cord

• the AC cord retainer that provides strain relief for the AC power cord.

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Chapter 4: Setting up and Starting the Synchrony

4.1 Preparing the Synchrony

4.1.1 SUMMARY OF SETUP OPERATIONS

4-1

Step 1 Install the inlet air filters.

See Section 4.1.2.

Step 2 Assemble and attach the patient circuit.

See Section 4.1.3

See Sections 4.1.4 to 4.1.6.

Step 4 Set up the patient parameters using the control panel.

Step 3 Provide power and set up the patient.

See Section 4.2.

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4-2

4.1.2 INSTALLING THE AIR FILTERS

The Synchrony uses one or two removable filters at the air inlet. You must install the gray foam filter before operating the Synchrony. The gray foam filter is washable and reusable. The disposable white ultra-fine filter is optional.

CAUTION: A properly installed, undamaged gray foam inlet filter is required for proper operation.

STEP 1 Place the gray foam filter on top of the ultra-

fine filter (if using the ultra-fine filter).

STEP 2 Slide the filters into the air inlet at the rear of

Reusable Gray

Foam Filter

Air Filter

Cover

Disposable Ultra-fine

Filter

STEP 3 Place the bottom of the air filter cover into the

STEP 4 Swing the top of the cover into place and press

See Chapter 11 to clean or replace the filters.

the Synchrony and push them down into the recess as shown in Figure 4-1.

bottom of the air inlet opening, making sure that the catches engage the lip of the opening.

down on the cover to engage the catches in the air inlet opening. See Figure 4-2.

Figure 4-1 Installing the Air Filters

Figure 4-2 Replacing the Air Filter Cover

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4.1.3 ASSEMBLING THE PATIENT CIRCUIT

WARNING: The exhalation device (e.g., the Whisper Swivel® II) or exhalation port (on masks with integrated

exhalation port) is designed to exhaust CO2 from the patient circuit. Do not block or seal the ports on the exhalation device.

WARNING: The oxygen valve must be installed and used if oxygen is to be titrated to the patient circuit. See

Chapter 10 for complete details.

STEP 1 Assemble the patient circuit according to the configurations

presented in Chapter 12.

STEP 2 If required, connect a bacteria filter to the patient interface port

(shown in Figure 4-3), and connect the patient tubing to the outlet of the bacteria filter.

• If the bacteria filter is not required, connect the patient tubing directly to the patient interface port.

4-3

• If oxygen is to be used, connect it according to Chapter 10.

• If a humidifier is to be used, connect the inlet to the bacteria filter outlet or to the patient interface port.

A completed assembly is shown in Figure 4-3.

Patient Interface

(Typical)

Exhalation Port

(Typical)

Circuit

Tubing

Oxygen

Valve

(Optional)

Bacteria

Filter

(Optional)

Patient

Interface

Port

Figure 4-3 An example of a Respironics-approved circuit

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4-4

4.1.4 SUPPLYING POWER TO THE SYNCHRONY

WARNING: The Synchrony can operate on AC or DC power. The DC power option is not intended as a battery

backup during use of AC power.

CAUTION: When DC power is obtained from a vehicle battery, the Synchrony should not be used while the

engine of the vehicle is running. Damage to the vehicle may occur.

AC OPERATION

Figure 4-4 Plugging in the AC Cord

DC OPERATION

Plug the electrical cord into the AC inlet in the back of the Synchrony, then plug the electrical cord into an outlet that is not controlled by a wall switch.

NOTE: Use the AC cord retainer to provide strain relief for the AC power cord.

STEP 1 Plug the DC cord connector into the rear of the Synchrony. STEP 2 Leaving a small amount of slack in the cord, press the cord into the

DC cord retainer.

STEP 3 Connect the DC cord to the appropriate DC source.

CAUTION: Only use a Respironics-

supplied DC cord.

DC Cord Retainer

Figure 4-5 Plugging in the DC Cord

Refer to the DC cord instruction sheet for recommended DC power sources.

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4-5

4.1.5 OPTIONAL INTERNAL

The optional internal modem is set up as shown in Chapter 7.

MODEM

4.1.6 PERFORMANCE VERIFICATION

When the initial setup is complete, perform the performance verification as described in Chapter 13.

4.2 Setting Up the Synchrony

Before using the Synchrony on a patient, set the prescription:

4.3 Connecting the Patient

SYNCHRONY S

MR. SMITH

NOTE: If your device is a system

for home use, “S” or “S/T” will appear on the startup screen--depending on the model. If your device is a Lab System, “LAB” will appear before “S” or “S/T” on the startup screen.

STEP 1 Press and release the Standby key.

STEP 2 If a Plateau Exhalation Valve (PEV) is used, enable the PEV option

STEP 3 If oxygen is being used, turn on the oxygen flow. Always turn the

1. To change the mode of operation, see Chapter 6.

2. To change the parameters, see Chapter 5.

3. To view or change the options, see Chapter 7.

4. Set the necessary alarms (see Section 8.2).

The start-up screen is displayed, then the Synchrony initiates a selftest. Both alarm LED indicators light momentarily, the audible alarm beeps twice to verify that the audible alarm is functioning. The start-up screen is then displayed, followed by the self-test screen. If the indicators do not light, or the audible alarm does not beep twice, the Synchrony requires service.

(see Section 7.2.5).

Synchrony on before turning on the oxygen, and always turn the oxygen off before turning off the Synchrony.

NOTE: If you have entered a

patient ID for the device (see Section 7.2.4), that text will also appear on the startup screen.

STEP 4 Place the mask on the patient. STEP 5 When the setup is complete place the Synchrony in Lockout

(see Section 7.2.6).

See Chapter 8 for alarm information.

See Chapter 10 if you are administering oxygen to the patient.

NOTE: Before placing the patient

on the Synchrony, check the integrity of the patient circuit, the exhalation port, and the alarms.

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4-6

4.4 Operating the System

Full Access Lockout

During operation, the screen shows Monitoring Screen 1 (see Section 3.3). To change patient controls, go to the Patient Controls screen. To change parameters, go to the Caregiver Menu screen. The display returns to Monitoring Screen 1 if no keys are pressed for one minute.

MODE: S 1/4 IPAP XX cm H2O EPAP XX cm H2O RR XXX BPM

MODE: S 2/4 Vt

1570 ml MinVent 20 L/min TotLeak 7 L/min

Monitoring

Screen 1

Monitoring

Screen 2

MODE: S 1/2 IPAP XX cm H2O EPAP XX cm H2O RR XXX BPM

CONTROLS: 2/2 Rise Time: 3 Dial Provider

Monitoring

Screen

Patient

Controls

CONTROLS: 3/4 Rise Time: 3 Dial Provider

SETUP: 4/4 Parameters Alarms Mode Options

Patient

Controls

NOTE: If the backlight is off, the first press of the , ,

or key will only turn the backlight on. All

procedures assume the backlight is already on.

Provider

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4.5 Patient Operating Instructions

With the Synchrony in Lockout, the patient is restricted to viewing only the pressure levels and the respiratory rate. The patient may change the Rise Time, dial the provider with the modem, and initiate the ventilation ramp.

4-7

4.5.1 SETTING THE RISE TIME

The Rise Time parameter is adjustable so that the patient can find the most comfortable setting. To change the Rise Time:

PATIENT ACTION RESULT

STEP 1 From the Monitoring Screen, press the DOWN

key to display the Patient Controls

MODE: S 1/4 IPAP 12 cm H2O EPAP 05 cm H2O RR 18 BPM

STEP 2 Press the ENTER key to activate the Rise Time

control.

NOTE: If the backlight is off, the first press of the , ,

or key will only turn the backlight on. All procedures assume the backlight is already on.

CONTROLS: 3/4 Rise Time: 3 Dial Provider

STEP 3 Press the DOWN or UP key to adjust the Rise

Time.

STEP 4 Allow the machine to cycle several times to see

if it feels better. Press ENTER to return to the control selection screen.

CONTROLS: 3/4 Rise Time: 3 Dial Provider

CONTROLS: 3/4 Rise Time: 4 Dial Provider

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4-8

4.5.2 DIALING THE PROVIDER

When instructed to do so, the patient can upload data from the Synchrony with the modem. The instructions to program the modem are in Section 7.2.4. The Synchrony can be in use by the patient while downloading data.

PATIENT ACTION RESULT

STEP 1 If you are using an external modem, attach the

RS 232 cable from the Synchrony to the modem.

If you are connecting an external modem through a telephone line, plug a telephone line from the rear of the Synchrony to a convenient telephone outlet.

NOTE: Items within the dashed line must be at

least six feet away from the patient.

NOTE: See Appendix A for external modem

requirements.

To A C

Power Source

6-ft RS232

Cable

Internal Modem Connection

Telephone

Modem

RS232

Connector

Telephone

Outlet

External Modem Connection

STEP 2 From the Monitoring Screen, press the DOWN

key to display the Patient Controls

MODE: S 1/4 IPAP 12 cm H2O EPAP 05 cm H2O RR 18 BPM

STEP 3 Press the DOWN key to select the Dial Provider

command, then press ENTER to dial the caregiver and send the report.

CONTROLS: 3/4 Rise Time: 3 Dial Provider

SENDING REPORT

STATUS: Dialing ABORT

The STATUS changes from “Dialing” to “Connected” to “Complete” under normal circumstances.

If you press ENTER when ABORT is displayed in the Call screen, the call will stop and the screen will go to STATUS: Complete.

NOTE: The word “Provider” on the Synchrony display screen can be replaced by an alphanumeric string you enter. See

the Section 7.2.4 for details.

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To send a report before therapy is started:

4-9

PATIENT ACTION

STEP 1 With the Synchrony not running, press the

STANDBY key.

STEP 2 When the self-test screen appears, press the

UP key.

STEP 3 Press the UP or DOWN key to select the Dial

Provider Command, then press ENTER.

The start-up screen is displayed, followed by the self-test screen.

The Dial Provider screen is displayed.

The STATUS changes from “Dialing” to “Connected” to “Complete” under normal circumstances.

If you press ENTER when ABORT is displayed in the Call screen, the call will stop and the screen will go to STATUS: Complete.

4.5.3 DATA TRANSMISSION ERRORS

STATUS Possible

Message Cause What to Do

No Modem Modem is not installed Call your home care provider.

properly or not connected correctly.

RESULT

No Dial Tone A phone is off the hook Press to exit, check the telephone line connection. Lift the receiver of

or telephone line is your telephone to make sure that you have a dial tone. not working.

Line Busy The provider’s line is The Synchrony will try to make the connection again after a slight delay.

in use. Press if you wish to stop the redialing. You should set the modem to try

several times before stopping.

Send Failed 1. If occurs shortly after 1. Press to exit. Provide a phone number.

first try, the Synchrony does not have a phone number entered into it.

2. If occurs after many 2. Press to exit; try again later. “Line Busy” and “Retry” messages, the Synchrony tried too many times, with the line busy.

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4-10

4.5.4 USING THE RAMP FUNCTION

The Synchrony is equipped with a ramp function that starts the IPAP pressure at the EPAP level. The IPAP pressure is increased at each breath until the full prescription level is reached. You set the increment per breath and enable or disable the ramp as shown in Section 5.2.

Figure 4-6 illustrates the ramp function.

IPAP

LEVEL

EPAP

Ramp

Increment

(Set by

Home Care

Provider)

LEVEL

1 Breath

Figure 4-6 The Synchrony Ramp Function

To start the Ramp feature, press . The Ramp indicator will be shown at the top of the display.

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Chapter 5: Changing Parameters

5.1 Summary of Change Parameters Operations

Full Access Only

MODE: S 1/4 IPAP 15 cm H2O EPAP 6 cm H2O RR 20 BPM

5-1

NOTE: The “X” shown in the hand

means that multiple presses are required to attain the next screen shown.

S Mode

S PARAMETERS: 1/2 IPAP 19 19 cm H2O EPAP 5 5 cm H2O Rise Time 3

S PARAMETERS: 2/2 VentRamp OFF Bi-Flex OFF EXIT

SETUP: 4/4 Parameters Alarms Mode Options

CPAP Mode

CPAP PARAMETERS: CPAP 10 10 cm H2O VentRamp OFF EXIT

T, PC, S/T Modes

XX PARAMETERS: 1/3 IPAP 19 19 cm H2O EPAP 5 5 cm H2O Rate 20 20 BPM

XX PARAMETERS: 2/3 Timed Insp 1.0 sec Rise Time 3

NOTE: If the backlight is off, the first press of the ,

, or key will only turn the backlight on; the normal key action is suppressed until the key is pressed a second time. All procedures assume the backlight is already on.

XX PARAMETERS: 3/3 VentRamp OFF

EXIT

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5-2

5.2 Change Parameters Screens

5.2.1 CPAP MODE

CPAP PARAMETERS: CPAP 10 10 cm H2O VentRamp OFF EXIT

Parameter Range of Change

CPAP 4 to 20 cm H2O 1 cm H2O Ventilation Ramp Disabled, 0.5, 1.0, 2.0, 3.0 cm H2O per breath Discrete values as listed

Increment

5.2.2 S MODE

S PARAMETERS: 1/2 IPAP 19 19 cm H2O EPAP 5 5 cm H2O Rise Time 3

Screen Increment

Number Parameter Range of Change

Screen 1 of 2 IPAP 4 to 30 cm H2O 1 cm H2O

EPAP 4 to 25 cm H2O 1 cm H2O Rise Time 1 to 6 1

Screen 2 of 2 Ramp Disabled, 0.5, 1.0, 2.0, 3.0 cm H2O per breath Discrete values as listed

Bi-Flex OFF, 1, 2, 3 Discrete values as listed

S PARAMETERS: 2/2 VentRamp OFF Bi-Flex OFF EXIT

NOTE: IPAP cannot be set lower than EPAP.

When Bi-Flex is enabled, Rise Time is set to 3 (0.3 seconds).

When Bi-Flex is enabled, then IPAP and EPAP are limited to 20 cm.

The Rise Time of 1 to 6 corresponds to tenths of a second (e.g., a setting of 4 equals 0.4 second rise time).

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5.2.3 T, PC, AND S/T MODES

XX PARAMETERS: 3/3 VentRamp OFF

EXIT

5-3

XX PARAMETERS: 1/3 IPAP 19 19 cm H2O EPAP 5 5 cm H2O Rate 20 20 BPM

XX PARAMETERS: 2/3 Timed Insp 1.0 sec Rise Time 3

Screen Increment

Number Parameter Range of Change

Screen 1 of 3 IPAP 4 to 30 cm H2O 1 cm H2O

EPAP 4 to 25 cm H2O 1 cm H2O Rate 0 to 30 BPM (PC and S/T) 1 BPM

4 to 30 BPM (T) 1 BPM

Screen 2 of 3 Timed Inspiration 0.5 to 3.0 sec 0.1 sec

Rise Time 1 to 6 1

Screen 3 of 3 Ramp Disabled, 0.5, 1.0, 2.0, 3.0 cm H2O per breath Discrete values as listed

NOTE: IPAP cannot be set lower than EPAP.

The Rate and Timed Inspiration controls are linked so that the inspiratory time is never longer than the expiratory time. If the Rate or Timed Inspiration are set to values that would cause the I:E ratio to exceed 1:1, the Timed Inspiration is automatically reduced to maintain a 1:1 I:E ratio.

The Rise Time of 1 to 6 corresponds to tenths of a second (e.g., a setting of 4 equals 0.4 seconds rise time).

WARNING! High EPAP pressures could cause discomfort to the patient. Carefully evaluate the patient if you set

the EPAP level above 15.

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5-4

5.3 Changing Synchrony Parameters

This section details the steps required to change parameters while in a given operating mode. For this example, the Synchrony is operating in the S mode.

YOUR ACTION

STEP 1 From the Monitoring screen, press the DOWN

key until the Setup screen is displayed.

MODE: S 1/4 IPAP 15 cm H2O EPAP 6 cm H2O RR 20 BPM

STEP 2 Press the ENTER key to activate the Change

Parameters screen, then press the ENTER key to activate the IPAP parameter for change.

RESULT

SETUP 4/4 Parameters Alarms Mode Options

S PARAMETERS: 1/2 IPAP 19 19 cm H2O EPAP 5 5 cm H2O Rise Time 3

STEP 3 Press the UP or DOWN key change the value.

Each key press changes the value by one increment. Press the ENTER key to select the next parameter.

STEP 4 Continue changing parameters: press the UP or

DOWN key to select a parameter, press the ENTER key to activate the parameter for change, use the UP or DOWN key to change the value, and press the ENTER key to retain the change.

When you reach the last parameter on a page, press the DOWN key to scroll to the next page.

S PARAMETERS: 1/2 IPAP 19 15 cm H2O EPAP 5 5 cm H2O Rise Time 3

S PARAMETERS: 1/2 IPAP 15 15 cm H2O EPAP 5 5 cm H2O Rise Time 3

NOTE: To move from one screen to another, press the

DOWN key when the selection indicator is at the last selectable item on the screen; or press the UP key when the selection indicator is at the first item.

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5-5

YOUR ACTION

STEP 5 Scroll to page 2 of the S Parameters screens.

Select the EXIT command and press the ENTER key to return to the Setup screen.

RESULT

S PARAMETERS: 2/2 VentRamp OFF Bi-Flex OFF EXIT

SETUP 4/4 Parameters Alarms Mode Options

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5-6

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Chapter 6: Changing Modes

6.1 Summary of Change Mode Operations

Full Access Only

6-1

MODE: S 1/4 IPAP XX cm H2O EPAP XX cm H2O RR XXX BPM

CONTROLS: 3/4 Rise Time: 3 Dial Caregiver

SETUP: 4/4 Parameters Alarms Mode Options

MODE: S

New Mode: S/T EXIT

Select using

UP or DOWN

key

NOTE: The “X” shown in the hand

MODE: S

New Mode: S/T EXIT

means that multiple presses are required to attain the next screen shown.

S Mode

SETUP MODE: S 1/2 IPAP 12 cm H2O EPAP 6 cm H2O Rise Time 3

CPAP Mode

SETUP MODE: CPAP CPAP 10 cm H2O VentRamp OFF START ABORT

SETUP: 4/4 Parameters Alarms Mode Options

MODE: S

New Mode: S/T EXIT

SETUP MODE: S 2/2 VentRamp OFF Bi-Flex OFF START ABORT

NOTE: If the backlight is off, the first press of the , , or

key will only turn the backlight on; the normal key action is suppressed until the key is pressed a second time. All procedures assume the backlight is already on.

T, PC, S/T Modes

SETUP MODE: X 1/3 IPAP 12 cm H2O EPAP 6 cm H2O Rate 10 BPM

SETUP MODE: X 2/3 Timed Insp 1.0 sec Rise Time 3

SETUP MODE: X 3/3 VentRamp OFF

START ABORT

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6-2

6.2 Change Mode Setup Screens

6.2.1 CPAP MODE SETUP SCREEN

SETUP MODE: CPAP CPAP 10 cm H2O VentRamp OFF START ABORT

6.2.2 S MODE SETUP SCREENS

See Section 5.2.1 for parameter ranges and increments.

SETUP MODE: S 1/2 IPAP 12 cm H2O EPAP 6 cm H2O Rise Time 3

SETUP MODE: S 2/2 VentRamp OFF Bi-Flex OFF START ABORT

6.2.3 T, PC, AND S/T MODES SETUP SCREENS

SETUP MODE: X 1/3 IPAP 12 cm H2O EPAP 6 cm H2O Rate 10 BPM

SETUP MODE: X 2/3 Timed Insp 1.0 sec Rise Time 3

See Section 5.2.2 for parameter ranges and increments.

SETUP MODE: X 3/3 VentRamp OFF

START ABORT

See Section 5.2.3 for parameter ranges and increments.

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6.3 Changing the Synchrony Mode

This section details the steps required to change the operating mode. For this example, the Synchrony is operating in the CPAP mode and will be changed to the S mode.

6-3

YOUR ACTION

STEP 1 From the CPAP monitoring screen, press the

DOWN key until the Mode command is selected in the Setup screen.

MODE: CPAP 1/4 CPAP 10 cm H2O RR 20 BPM Vt 1570 ml

STEP 2 Press the ENTER key twice to activate the

Change Mode screen and the New Mode command.

RESULT

SETUP: 3/3 Parameters Alarms Mode Options

MODE: CPAP

New Mode: CPAP EXIT

STEP 3 Press the UP key once to select S, then press the

ENTER key to implement the change.

MODE: CPAP

New Mode: CPAP EXIT

MODE: CPAP

New Mode: S EXIT

SETUP MODE: S 1/2 IPAP 12 cm H2O EPAP 6 cm H2O Rise Time 3

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6-4

YOUR ACTION

STEP 4 a. Press the ENTER key to activate the IPAP

parameter for change

b. Press the UP or DOWN key to change the IPAP value. Each key press changes the value by one increment (see Section 5.3).

c. Press the ENTER KEY to implement the change.

STEP 5 Continue changing parameters: press the UP or

DOWN key to select a parameter, press the ENTER key to activate the parameter for change, use the UP or DOWN key to change the value, and press the ENTER key to implement the change.

RESULT

SETUP MODE: S 1/2 IPAP 12 cm H2O EPAP 6 cm H2O Rise Time 3

SETUP MODE: S 1/2 IPAP 11 cm H2O EPAP 6 cm H2O Rise Time 3

NOTE: To move from one screen to another, press the

DOWN key when the selection indicator is at the last selectable item on the screen; or press the UP key when the selection indicator is at the first item.

STEP 6 Scroll to page 2 of 2 and press the DOWN key

to select the START command.

SETUP MODE: S 2/2 VentRamp OFF Bi-Flex OFF START ABORT

NOTE: To exit the setup mode without initiating a new mode, press the DOWN key to select the ABORT command, then press the ENTER key.

STEP 7 Press the ENTER key to implement the

S mode at the selected settings.

NOTES: The current mode remains active until the START command is implemented with the ENTER key.

MODE: S 1/4 IPAP 15 cm H2O EPAP 5 cm H2O RR 20 BPM

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Chapter 7: Options

7.1 Summary of Options Operations

MODE: S 1/4 IPAP 15 cm H2O EPAP 6 cm H2O RR 20 BPM

7-1

NOTE: The “X” shown in the hand means that multiple

presses are required to attain the next screen shown.

SETUP 4/4 Parameters Alarms Mode Options

OPTIONS: 1/3 Time at P 100hrs System Codes Pt Alarm History

NOTE: If the backlight is off, the first press of the ,

, or key will only turn the backlight on; the normal key action is suppressed until the key is pressed a second time. All procedures assume the backlight is already on.

OPTIONS: 2/3 Modem PEV: NO Lockout: NO

OPTIONS: 3/3 Language: ENGLISH Alarm: LOUD EXIT

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7-2

7.2 Synchrony Options Menu

The Options menu allows you to:

• view and reset the Time at P (Time at Pressure)

• view and clear the System Codes and the Pt Alarm History (Patient Alarm History)

• view and change the Modem settings

• adjust leak determination for the Plateau Exhalation Valve (PEV)

• change the access level

• modify the language

• modify the alarm volume

7.2.1 TIME AT PRESSURE

The Time at P display shows the time, in hours, that the Synchrony has run at the prescribed pressure. The time is accumulated for bi-level modes when the IPAP pressure is within 2 cm H2O of the set pressure; for the CPAP mode, time is accumulated when a breath is triggered. The time can be cleared.

To view or clear the Time at P display:

YOUR ACTION RESULT

STEP 1 From the Options menu, press the UP or

DOWN key to select the Time at P display.

OPTIONS: 1/3 Time at P 25hrs System Codes Pt Alarm History

STEP 2 Press the ENTER key to activate the Time at P

reset screen then press the UP key to select the CLEAR command.

STEP 3 Press the ENTER key to reset the Time at

Pressure hours.

TIME AT P:

25.1 hours

CLEAR EXIT

TIME AT P:

25.1 hours

CLEAR EXIT

OPTIONS: 1/3 Time at P 0hrs System Codes Pt Alarm History

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7-3

7.2.2 SYSTEM CODES

The Synchrony stores the system error codes in the system alarm log. These codes can be used by authorized service representatives to troubleshoot the ventilator. The Synchrony can store five pages of 10 codes per page. Appendix B lists the error codes.

The Error Code Screen also allows you to clear all the currently-stored codes.

YOUR ACTION RESULT

STEP 1 From the Options menu, press the DOWN key

until the System Codes command is selected, then press the ENTER key to display the System Codes screen.

OPTIONS: 1/3 Time at P 25 hrs System Codes Pt Alarm History

OPTIONS: 1/3 Time at P 50hrs System Codes Pt Alarm History

SYSTEM CODES: 1/1 067 011 009

CLEAR EXIT

STEP 2 Press the ENTER key to Exit the screen. If

there are more than one page of codes, press the DOWN key to scroll through the screens. The final screen will display the EXIT command. To exit the system codes, press ENTER. To clear the system codes when the CLEAR command is displayed, press the UP key then the Enter key.

OPTIONS: 1/3 Time at P 50hrs System Codes Pt Alarm History

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7-4

7.2.3 PATIENT ALARM HISTORY

The Synchrony stores the patient alarms such that the most recent alarm appears first in the patient alarm log. The Synchrony can store 20 pages with two alarm messages per page.

YOUR ACTION RESULT

STEP 1 From the Options menu, press the DOWN key

until the Patient Alarm History command is selected, then press the ENTER key to activate.

OPTIONS: 1/3 Time at P 25hrs System Codes Pt Alarm History

STEP 2 Press the ENTER key to Exit the screen. If

there are more than one page of history, press the DOWN key to move to the Exit screen, then press ENTER. To clear the alarm history when the CLEAR command is displayed, press the UP key then the Enter key.

OPTIONS: 1/3 Time at P 25hrs System Codes Pt Alarm History

PT ALARMS: 1/1 Apnea

CLEAR EXIT

OPTIONS: 1/3 Time at P 25hrs System Codes Pt Alarm History

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7-5

7.2.4 MODEM SETTINGS

The Modem Settings screens display and allow you to change the modem type (external or internal), modem speed, phone number to be dialed, and the modem initialization string. (See Appendix A for external modem considerations.)

YOUR ACTION RESULT

STEP 1 From the Options menu, press the DOWN key

until the Modem command is selected, then press the ENTER key to activate the Modem Settings screen.

OPTIONS: 1/3 Time at P 25 hrs System Codes Pt Alarm History

STEP 2 Press the ENTER key to activate the Type for

change.

OPTIONS: 2/3 Modem PEV: NO Lockout: NO

MODEM SETTINGS: 1/6 Type: Ext. 19200 Dial: ATDT*70,4125551212

STEP 3 Press the UP or DOWN key to toggle the

modem types.

STEP 4 Press the ENTER key when your modem type

is displayed. If your Synchrony was purchased with the optional internal modem, select Internal.

The choices are:

• Internal

• External 57600

• External 38400

• External 9600

• External 2400

• None

• External 19200

NOTE: For all screens, you can hold in the UP or

DOWN key to quickly scroll through the choices.

MODEM SETTINGS: 1/6 Type: Ext. 19200 Dial: ATDT*70,4125551212

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7-6

NOTE: In the remainder of the modem setup steps, you can select a

press the ENTER key when the to the left of the

↵↵

↵ are accepted.

↵↵

↵ is displayed, all characters to the right of the

↵↵

YOUR ACTION RESULT

STEP 5 Press the ENTER key to activate the Dial

parameters for change.

STEP 6

The first parameter under Dial sets the type of line service the patient will be using. Press the UP or DOWN key to scroll through the options:

• ATDT for tone dialing

• ATDP for pulse dialing

• ↵ to leave the phone number blank

Press the ENTER key when the desired setting is displayed. The Navigation Indicator moves one character to the right.

↵↵

↵ character in the text string selections. If you

↵↵

↵ are deleted; all characters

↵↵

MODEM SETTINGS: 1/6 Type: Ext. 19200 Dial: ATDT 70,4125551212

MODEM SETTINGS: 1/6 Type: Ext. 19200 Dial: ATDT* 0,4125551212

STEP 7

The remaining characters are selected one at a time, and are used to set the number to dial. This includes any prefixes, such as *70. Use the UP or DOWN arrow keys to scroll through:

• 1 to 9

• , (comma)

Press the ENTER key when the desired character is displayed; the Navigation Indicator moves one character to the right.

• * (asterisk)

• ↵ (enter)

STEP 8

At the final digit of the phone number, press the ENTER key to move one character to the right; scroll to the ↵ symbol.

Press the ENTER key, then the DOWN key. The Modem Settings screen scrolls to page 2 of 6.

NOTE: The comma is used to place a pause between

inputs, such as after *70; the * is used to access special phone options, such as disabling call waiting. No dashes are used in the phone number. The maximum number of characters is 15.

MODEM SETTINGS: 1/6 Type: Ext. 19200 Dial: ATDT*7 ,4125551212

MODEM SETTINGS: 1/6 Type: Ext. 19200 Dial: ATDT*70,4125551212↵

MODEM SETTINGS: 2/6 INIT 1: AT&FV0E1Q0

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YOUR ACTION RESULT

STEP 9

If you have the internal modem installed, the modem initialization strings are automatically entered, and cannot be changed. Press the DOWN key twice and skip to Step 11.

For external modems, see Appendix A for recommended initialization strings.

Press the ENTER key to activate the Initialization String 1 for change.

The navigation of the string works the same as for the phone number entry of Step 7, except the character set is:

7-7

• A to Z

• 0 to 9

• & (ampersand)

• % (percent)

• # (pound sign)

The maximum number of characters is 20. When you have entered the desired initialization string, move one character to the right, scroll to the ↵ symbol, and press the ENTER key then press the DOWN key. The screen scrolls to Page 3 of 6, Init 2.

• = (equal)

• + (plus)

• - (minus)

• \ (backslash)

• ↵ (enter)

STEP 10

Enter the Init 2 string as shown in Appendix A. The navigation and change operation is the same as in Step 9.

The maximum number of characters is 20. When you have entered the desired initialization string, move one character to the right, scroll to the ↵ symbol, and press the ENTER key. The screen scrolls to page 4 of 6, Patient ID.

MODEM SETTINGS: 3/6 INIT 2: AT&FV0E1Q0

MODEM SETTINGS: 4/6 Patient ID: MR. SMITH

STEP 11

The Patient ID screen is used to identify the patient for your records. The navigation of the ID string works the same as for the phone number in Step 7, except the character set is:

• A to Z

• 0 to 9

• _ (underscore)

• # (pound sign)

NOTE: The patient ID text will appear on the start-up screen. (See Section 4.3).

• (space)

• - (minus)

• . (period)

• ↵ (enter)

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7-8

YOUR ACTION RESULT

STEP 12

The Provider screen is used to identify your company to the patient. It is shown in place of “Provider” in the Call Provider screen. The navigation of the ID string and the character set are the same as for the Patient ID of Step 10.

STEP 13

The Serial Number is the serial number of the Synchrony. It is factory-set and cannot be changed. You may use the number for tracking purposes.

MODEM SETTINGS: 5/6 Provider: HEALTH CARE

MODEM SETTINGS: 6/6 Serial Number: 012345 EXIT

Press the ENTER key to exit the Modem Setting screens and return to the Options menu.

OPTIONS: 2/3 Modem PEV: NO Lockout: NO

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7-9

7.2.5 PEV SETTING

The PEV parameter is provided to compensate for the different leak characteristics when using a Respironics Plateau Exhalation Valve (PEV). The PEV setting is stored in memory and must be changed if you are changing from or to a PEV after restarting the Synchrony.

WARNING: The PEV parameter must be set to YES if a PEV is in the patient circuit. Failure to set the parameter

correctly can result in inaccurate leak and tidal volume measurements.

YOUR ACTION RESULT

STEP 1 From the Options menu, press the DOWN key

until the PEV parameter is selected, then press the ENTER key.

OPTIONS: 1/3 Time at P 25 hrs System Codes Pt Alarm History

OPTIONS: 2/3 Modem PEV: NO Lockout: NO

STEP 2 Press the UP or DOWN key to toggle the value

of the PEV parameter.

STEP 3 Press the Enter key to accept the change to the

PEV parameter.

OPTIONS: 2/3 Modem PEV: YES Lockout: NO

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7-10

7.2.6 CHANGING THE ACCESS LEVEL

YOUR ACTION RESULT

STEP 1 From the Options menu, press the DOWN key

until the Lockout command is selected, then press the ENTER key.

OPTIONS: 1/3 Time at P 25 hrs System Codes Pt Alarm History

STEP 2 Press the UP or DOWN key to toggle the

Lockout command between YES and NO.

STEP 3 Press the ENTER key to implement the

Lockout command.

OPTIONS: 2/3 Modem PEV: YES Lockout: NO

OPTIONS: 2/3 Modem PEV: YES Lockout: YES

7.2.7 UNLOCKING THE ACCESS LEVEL

NOTE: The Lockout command change does not take

effect until you exit the Options menu.

After the unit is set to Lockout, you may access the Setup screen by simultaneously pressing and holding the RAMP and ENTER keys for one second.

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7.2.8 CHANGING THE LANGUAGE

YOUR ACTION RESULT

STEP 1 From the Options menu, press the DOWN key

until the Language command is selected, then press the ENTER key.

OPTIONS: 1/3 Time at P 25 hrs System Codes Pt Alarm History

7-11

OPTIONS: 3/3 Language: ENGLISH Alarm: LOUD EXIT

STEP 2 Press the UP or DOWN key to scroll through

the available languages, then press the ENTER key to implement the language change.

OPTIONS: 3/3 Language: FRAN AIS Alarm: LOUD EXIT

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7-12

7.2.9 CHANGING THE ALARM VOLUME

YOUR ACTION RESULT

STEP 1 From the Options menu, press the DOWN key

until the Alarm command is selected, then press the ENTER key.

OPTIONS: 1/3 Time at P 25 hrs System Codes Pt Alarm History

STEP 2 Press the UP or DOWN key to toggle between

LOUD and SOFT, then Press the ENTER key to implement the Alarm volume change.

OPTIONS: 3/3 Language: ENGLISH Alarm: LOUD EXIT

OPTIONS: 3/3 Language: ENGLISH Alarm: SOFT EXIT

7.2.10 EXITING THE OPTIONS MENU

YOUR ACTION RESULT

STEP 1 Press the UP or DOWN key to return to

Options screen 3/3.

STEP 2 Press the UP or DOWN key to select EXIT,

then press the ENTER key.

OPTIONS: 3/3 Language: ENGLISH Alarm: LOUD EXIT

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Chapter 8: Alarms

8.1 Alarm Introduction

8-1

This chapter describes the Synchrony alarms, describes how to set them, and lists corrective actions for the alarm conditions.

The Synchrony provides three alarm levels: high, medium, and low priority.

High priority alarms require immediate operator response. The alarm signal consists of a red LED and a high priority sound. The display has the message “ALARM” at the top of the screen.

Medium priority alarms require prompt operator response. The alarm signal consists of a yellow LED and a medium priority sound. The display has the message “WARNING” at the top of the screen.

Low priority alarms require operator awareness. The alarm signal consists of a yellow LED and a low priority sound. The display has the message “INFO” at the top of the screen.

Some audible indicators are self-cancellable. This means that the alarm sound will stop when the cause of the alarm is corrected. See Section 8.3 for detailed descriptions of the alarm LEDs and sounds.

Figure 8-1 identifies the alarm LED locations on the control panel.

High Priority

Alarm LED

Low/Medium Priority

Alarm LED

Figure 8-1 Synchrony Alarm Indicators

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8-2

8.2 Setting Alarm Parameters

8.2.1 ALARM PARAMETER OPERATION SUMMARY

MODE: S 1/4 IPAP 15 cm H2O EPAP 6 cm H2O RR 20 BPM

NOTE: The “X” shown in the hand

means that multiple presses are required to attain the next screen shown.

NOTE: If the backlight is off, the

first press of the , , or

key will only turn the backlight on; the normal key action is suppressed until the key is pressed a second time. All procedures assume the backlight is already on.

SETUP: 4/4 Parameters Alarms Mode Options

ALARMS 1/2 Disconnect:OFF Apnea: OFF

ALARMS 2/2 LowMinVent:OFF

EXIT

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8-3

8.2.2 CHANGING THE ALARM PARAMETERS

CHANGING THE PATIENT

The Patient Disconnect Alarm Delay, the Apnea Alarm, and the Low Minute Ventilation Alarm are adjustable on the Synchrony. When any of these alarms are enabled, an inverse “A” appears at the top of the Monitoring screen. See Chapter 3 for details.

DISCONNECT ALARM DELAY

YOUR ACTION

STEP 1 From the Monitoring screen, press the DOWN

key until the Alarms command is selected.

MODE: S 1/4 IPAP 15 cm H2O EPAP 6 cm H2O RR 20 BPM

RESULT

SETUP 4/4 Parameters Alarms Mode Options

STEP 2 Press the ENTER key to activate the Alarms

screen, then press the ENTER key again to activate the Disconnect parameter for change.

STEP 3 Press the UP or DOWN key to change the

parameter, then press the ENTER key to implement the change.

STEP 4 Press the DOWN key twice, the press the

ENTER key to exit the Alarms screen.

ALARMS Disconnect:OFF Apnea:OFF

ALARMS 1/2 Disconnect:OFF Apnea: OFF

The settings are OFF, 15 seconds, and 60 seconds.

ALARMS Disconnect: 15 sec Apnea: OFF

ALARMS 2/2 LowMinVent:25 L/MIN

EXIT

SETUP 4/4 Parameters Alarms Mode Options

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8-4

CHANGING THE APNEA ALARM

NOTE: If you disable the apnea alarm, the system will not produce an

audible alarm. A record of the apnea will not appear in the Synchrony alarm log. However a record will appear in the Encore/ Encore Pro alarm log.

YOUR ACTION

STEP 1 From the Monitoring screen, press the DOWN

key until the Alarms command is selected.

MODE: S 1/4 IPAP 15 cm H2O EPAP 6 cm H2O RR 20 BPM

STEP 2 Press the ENTER key to display the Alarms

screen, press the DOWN key to select the Apnea parameter, then press the ENTER key to activate.

RESULT

SETUP 4/4 Parameters Alarms Mode Options

ALARMS 1/2 Disconnect:OFF Apnea: OFF

STEP 3 Press the UP or DOWN key to change the

parameter, then press the ENTER key to implement the change.

STEP 4 Press the DOWN key twice, then press the

ENTER key to exit the Alarms screen.

The settings are OFF, 10, 20, 30, 40 seconds.

ALARMS 1/2 Disconnect: 15 sec Apnea: OFF EXIT

ALARMS 1/2 Disconnect: 15 sec Apnea: 20 sec

ALARMS 2/2 LowMinVent:25 L/MIN

EXIT

SETUP 4/4 Parameters Alarms Mode Options

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CHANGING THE LOW MINUTE VENTILATION ALARM

8-5

YOUR ACTION

STEP 1 From the Monitoring screen, press the DOWN

key until the Alarms command is selected.

MODE: S 1/4 IPAP 15 cm H2O EPAP 6 cm H2O RR 20 BPM

STEP 2 Press the ENTER key to display the Alarms

screen, press the DOWN key twice to select the LowMinVent parameter, then press the ENTER key to activate.

RESULT

SETUP 4/4 Parameters Alarms Mode Options

STEP 3 Press the UP or DOWN key to change the

parameter, then press the ENTER key to implement the change.

STEP 4 Press the ENTER key to exit the Alarms screen.

ALARMS 2/2 LowMinVent:OFF

EXIT

The settings are OFF, 1 to 99 L/MIN.

ALARMS 2/2 LowMinVent:20 L/MIN

EXIT

ALARMS 2/2 LowMinVent:25 L/MIN

EXIT

SETUP 4/4 Parameters Alarms Mode Options

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8-6

8.3 Summary of Alarm Behavior

Alarm conditions are signaled by the Synchrony in three ways: a sound, an LED, and a display message. Each signal type behaves differently depending on the type of alarm.

8.3.1 ALARM SOUNDS BEHAVIOR

High Priority Sounds:

High Priority: The sound repeats a pattern of three beeps followed by two

beeps until the RAMP/SILENCE key is pressed. The silence period is one minute. This pattern is indicated in Section 8.5 by

Loss of Power: The sound is continuous for two minutes without user intervention. If the user presses the STANDBY key, the sound will terminate. There is no silence period for this sound. This pattern is indicated in Section 8.5 by

Synchrony Failure: In the event of a Synchrony failure, the alarm sounds in single beeps until power is removed from the Synchrony. It cannot be silenced except by removing power. This pattern is indicated in Section 8.5 by

Medium Priority Sound:

The sound repeats a pattern of three beeps every 20 seconds until the RAMP/SILENCE key is pressed. The silence period is one minute. The pattern is indicated in Section 8.5 by

Low Priority Sound:

The alarm repeats a pattern of two beeps every 30 seconds until the RAMP/ SILENCE key is pressed. The audible alarm will not reoccur. The pattern is indicated in Section 8.5 by

Silence Period

The alarm silence period, when applicable, is one minute. When the alarm sound is silenced, a flashing LED becomes continuous (see 8.3.2). If the alarm condition is not corrected by the end of the silence period, the alarm sound is repeated; the LED is not affected. If a new high or medium priority alarm condition occurs during this time, the appropriate LED will flash. New low priority alarms will not cause the LED to flash.

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8-7

8.3.2 ALARM LED BEHAVIOR

Red LED

• Flashing red LED indicates a new high priority alarm. The LED changes to continuous when the alarm sound is silenced or the alarm condition is corrected. The LED will resume flashing during the silence period if a new alarm occurs. The LED goes off when the alarm message is cleared.

• Continuous red LED indicates a loss of power or a silenced high priority alarm.

Yellow LED

• Flashing yellow LED indicates a new medium priority alarm. The LED changes to continuous when the alarm sound is silenced or the alarm condition is corrected. The LED will resume flashing during the silence period if a new medium priority alarm occurs. The LED goes off when the alarm message is cleared.

• Continuous yellow LED indicates a low priority alarm or a silenced medium priority alarm.

8.3.3 DISPLAY BEHAVIOR

The indicator is displayed next to an alarm message to indicate an active alarm condition. When the condition is corrected, the indicator is cleared.

For High Priority Alarms, the displays shows “ALARM” and the name of the alarm.

For Medium Priority Alarms, the display shows “WARNING” and the name of the alarm.

For Low Priority Alarms, the display shows “INFO” and the name of the alarm.

The display can contain multiple pages of alarms. The page number in the upper right of the display will indicate the page you are on and the total pages (e.g., 1/3). To access the other pages, press the UP or DOWN key.

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8-8

8.4 Summary of User Actions During Alarm

The following steps apply to most alarm conditions. The patient or operator should follow this sequence unless otherwise directed by the alarm table in Section 8.5.

STEP 1 Look at the alarm indicators and listen to the alarm sound.

STEP 2 Look at the display for text.

STEP 3 Press the RAMP/SILENCE key.

(Note color and whether LED is flashing or solid)

ALARM 1/1 Apnea

If more than one alarm is listed, the indicator shows which alarm is still active.

ALARM 1/1 Apnea

CLEAR

STEP 4 Press the Enter key to clear the alarm.

ALARM 1/1 Apnea

CLEAR

NOTE: For High and Medium Priority Alarms,

the indicator will go off when the alarm condition is corrected.

STEP 5 Look up the alarm in the alarm tables and

perform the Patient Action.

MODE: S 1/4 IPAP 15 cm H2O EPAP 6 cm H2O RR 20 BPM

Alarm CLEAR Screen is displayed Alarm LED is solid

indicator is off Alarm LED is solid

Alarm is reset Display returns to screen that was showing at time of alarm

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8.5 Alarm Tables

Sections 8.5.1 to 8.5.3 detail the alarms, display messages, Synchrony actions, possible causes, and patient and provider actions. The tables are arranged alphabetically, by priority. Note that the LED and Audible columns represent the conditions when the alarm is activated; all LEDs will be on and the audible will be silenced after you press the RAMP/ SILENCE key. Section 8.5.4 provides definitions for the alarms.

8.5.1 HIGH PRIORITY ALARMS

8-9

Red Solid

Red Flash

Display

AudibleLED

Message

Blank Screen

Synchrony

Action

Shuts down Device failure.Red Flash

Possible

Cause

Patient

Action

Cannot be silenced; remove power from the device, and

Provider

Action

Replace the device.

contact home care provider.

Blank Screen

Shuts down

Power was lost while the device was providing

None.Press to silence,

restore power.

therapy.

Apnea

High Pressure Malfunctioning

Operates Report alarm to

Operates None. If alarm

Apnea event occurred during therapy.

device.

your home care provider.

continues call your

Verify patient status.

Replace device.

home care provider.

Invalid Prescription Call Provider

Shuts down The prescription

data is corrupted.

Do not use the device; call your home care provider.

Re-enter prescription data or replace the device.

Red Flash

Optional

Low Pressure Excessive leak or

Operates Check for the

blockage.

Patient Disconnect

Operates Reconnect the

Patient circuit is disconnected or has a large leak.

following: dirty inlet filters, blocked air intake, excessive leak in patient circuit. If alarm continues, call your home care provider.

patient circuit or correct the leak.

NOTE: If therapy does not resume after you start breathing, (1) silence the alarm using the RAMP key, (2) clear the alarm using the ENTER key, and (3) press the RAMP key again to resume therapy. If the alarm continues, contact your home care provider.

Replace the device.

Reconnect the patient circuit or fix the leak. If the alarm continues, replace the device.

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8-10

AudibleLED

Display

Message

Red Flash

Optional

The error codes can be viewed upon start-up of the Synchrony on the self-test screen. The codes can also be viewed by

displaying the System Codes screen as described in Section 7.2.2. Appendix B lists the error codes and their descriptions.

Low Pressure Support

Low Minute Ventilation

Ventilator Inoperative (Displays Codes)

Ventilator Inoperative Battery Failure

Synchrony

Action

Operates

Shuts down Remove power

Shuts down Remove DC power

Possible

Cause

Device is malfunctioning.

Device sensed minute ventilation below alarm setpoint.

Internal device failure.

Battery is discharged.

Patient

Action

Call your home care provider.

Report alarm to your home care provider.

from the device. Call your home care provider.

source from the Synchrony, replace the battery, restore power to the Synchrony; or seek reliable AC power source.

Provider

Replace the device.

Verify patient status.

Replace the Synchrony.

Replace the battery.

Action

8.5.2 MEDIUM PRIORITY ALARMS

Display

AudibleLED

Yellow

Flash

Yellow

Flash

Message

Battery Voltage Too High

Low Battery Battery nearly

Synchrony

Action

Operates Remove DC power

Operates

Possible

Cause

Wrong or malfunctioning battery or charger.

discharged.

Patient

Action

from the device, use on AC, or call home care provider.

If on battery, replace battery; if on AC, exchange the battery and charge.

Provider

Action

Replace the battery.

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8.5.3 LOW PRIORITY ALARMS

8-11

Yellow

Solid

Yellow

Solid

Yellow

Solid

Yellow

Solid

Display

AudibleLED

Message

Battery in Use Operates

Call for Service (Codes are displayed)

Momentary Loss of Power

Power Failure, Battery in Use

Synchrony

Action

Operates

Possible

Cause

On start-up, information message that battery is being used to provide power.

Minor internal error.

Power was lost for less than two minutes while the Synchrony was providing therapy.

Line (AC) power was lost, the device is now operating on battery (DC) power.

Patient

Action

Press to confirm that you wish to operate on battery power.

Continue to use, write down error code, call your home care provider.

Press to clear the information message.

Check AC power, seek reliable power source.

Provider

Action

None.

Record the error code or message, replace the unit.

None.Operates

None.

The error codes can be viewed upon start-up of the Synchrony on the self-test screen. The codes can also be viewed by

displaying the System Codes screen as described in Section 7.2.2. Appendix B lists the error codes and their descriptions.

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8-12

8.5.4 ALARM DEFINITIONS

The following table lists each patient alarm with its purpose, detection parameters, and termination parameters.

Alarm

Apnea

High Pressure

Low Pressure

Patient Disconnect

Purpose

The apnea alarm detects the cessation of spontaneous breathing.

The high pressure alarm limits pressure to the patient.

The low pressure alarm detects when the patient is not receiving adequate pressure therapy.

The patient disconnect alarm detects when the patient is no longer connected to the Synchrony.

Detection

Alarm is detected when the time between spontaneous breaths exceeds the Apnea alarm time setting. The alarm is not detected during Flow Limit Control (FLC).

Alarm is detected when the pressure exceeds the IPAP setpoint by 5 cm H2O for a continuous 0.5 second.*

Alarm is detected when the pressure is below 5 cm H2O for 60 continuous seconds.

Alarm is detected when the Synchrony is in FLC and the Patient Disconnect Alarm is enabled. There is a 10-second delay between the time the Synchrony enters FLC and the alarm is generated.

Termination

The alarm is terminated when two consecutive spontaneous breaths occur within the Apnea alarm time setting.

The alarm is terminated when the pressure is within 5 cm H2O of the IPAP setpoint for a continuous 0.5 second.

The alarm is terminated when the pressure is within 5 cm H2O for a continuous

0.5 second.

The alarm is terminated when the Synchrony is no longer in FLC.

Low Pressure Support

Low Minute Ventilation

The low pressure support alarm detects when the patient is not receiving adequate pressure therapy.

The low minute ventilation alarm detects when the user is not receiving a specified volume of air on a per minute basis.

Alarm is detected when RXPS - MeasPS > PSmin cm H2O for 60 continuous seconds.**

Alarm is detected when the calculated minute ventilation ≤ the alarm setting. The alarm is not detected during FLC.

Alarm is terminated when RXPS - MeasPS ≤ PSmin cm H2O for 5 continuous seconds.

Alarm is terminated when the calculated minute ventilation > the alarm setting.

Synchrony waits 6 breaths after machine is started or after exiting FLC before detection.

* The Synchrony shuts down if the pressure exceeds IPAP by 5 cm H ** MeasPS = Measured Pressure Support (Attained IPAP - Attained EPAP); R

The following conditions must be satisfied for the Synchrony to be examined for a Low Pressure Support condition:

• RXPS > 3 cm H2O and RXPS < 10 cm H2O

• The Synchrony is not performing the Ramp function

• The Synchrony is not in FLC

• The respiratory rate is non-zero

O for 10 seconds.

PS = Prescription Pressure Support; PSmin = (RxPS + 2 cm H2O)/3

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Chapter 9: Communications

This chapter describes the ability of the Synchrony to communicate with the caregiver using the optional modem.

9.1 Communicating Via Optional Modem

The modem setup is described in Chapter 7.

Section 4.5.2 provides instructions to connect the Synchrony to a phone line and dial the provider.

9-1

9.2 Communicating With Encore

NOTE: Respironics Encore or Encore Pro software is required to extract compliance data.

The Encore or Encore Pro software can extract compliance data from the Synchrony. Use the Respironics-supplied RS-232 cable to connect the Synchrony to an IEC950, EN60950, or UL1950 approved device or computer with the Encore or Encore Pro software loaded. Figure 9-1 shows a typical setup.

See the Encore or Encore Pro software help files for information on running the software.

RS-232 Communication Connector

or Encore Pro Data Management Software

Figure 9-1 Typical Configuration for connecting a Synchrony to a Computer.

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9-2

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Chapter 10: Adding Supplemental Oxygen

You may add oxygen to the patient circuit using the optional oxygen valve. This chapter describes the method of oxygen delivery and shows the oxygen concentrations attained at various IPAP and EPAP settings and oxygen flow rates.

WARNING: Oxygen should be administered only on the order of a physician.

WARNING: Supplemental oxygen should not be added to the breathing circuit by placing the source where the gas will be

entrained through the inlet filter on the rear of the device.

WARNING: Never attach oxygen tubing or any positive pressure source to the Pressure Line Port on the front panel of the

Synchrony ventilator.

WARNING: Continuous patient monitoring is recommended while administering oxygen. Patient monitoring should consist of,

at a minimum, patient observation and pulse oximetry. Arterial blood gas measurements should be used when necessary.

WARNING: Oxygen supports combustion. Oxygen should not be used while the patient is smoking or in the presence of an

open flame.

WARNING: When administering fixed-flow supplemental oxygen, the oxygen concentration may not be constant. The inspired

oxygen concentration will vary, depending on the IPAP and EPAP settings, patient breathing pattern, and the leak rate. Substantial leaks around the mask may reduce the inspired oxygen concentration to less than the expected concentrations shown in Section 10.2. Appropriate patient monitoring should be implemented.

10-1

WARNING: When you are using oxygen with this system, the oxygen supply must comply with the local regulations for

medical oxygen.

WARNING: If oxygen is used with the Synchrony, the oxygen flow must be turned off when the Synchrony is not operating.

Explanation of the Warning: When the ventilator is not in operation, and the oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulated within the ventilator enclosure. Oxygen accumulated in the ventilator enclosure will create a risk of fire. This warning applies to most types of bi-level devices.

WARNING: Oxygen accelerates fires. Keep the Synchrony and the oxygen container away from heat, open flames, any oily

substance, or other sources of ignition. DO NOT smoke in the area near the Synchrony or the oxygen.

WARNING: If supplemental oxygen is added to the breathing circuit, the optional oxygen valve must be installed and used

as shown in Figure 10-1.

10.1 Adding Supplemental Oxygen

The delivered oxygen concentration varies with changes in flow in the circuit. The following may have an impact on oxygen concentration:

• Pressure settings

• Patient Tidal Volume

WARNING: If supplemental oxygen is added to the breathing circuit, the optional oxygen valve must be installed and used as shown in Figure 10-1.

• Peak Inspiratory Flow

• I:E Ratio

• Respiratory rate

• Circuit leak rate

• Oxygen flow rate

• Site where oxygen is added to the circuit.

To add oxygen to the circuit, the oxygen supply must comply with the local regulations for medical oxygen. The oxygen flow into the oxygen valve cannot exceed 15 L/min and the pressure cannot exceed 50 psi.

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10-2

Step 1 As shown in Figure 10-1, attach oxygen tubing from the oxygen

source to the “In” port on the oxygen valve.

Step 2 Connect a section of oxygen tubing to the “Out” valve port, then to

one of the ports on the mask (if so equipped) or to an O2 enrichment adaptor positioned in the patient circuit.

Step 3 Turn the Synchrony on. Step 4 Set the oxygen flow to the desired value.

Circuit

Tubing

Enrichment

Adaptor

From Oxygen

Source

Oxygen Tubing From Oxygen

Oxygen

Valve

Figure 10-1 Methods of Adding Oxygen to the Patient Circuit

Exhalation

Port

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10.2 Supplemental Oxygen Concentrations

Figures 10-2 and 10-3 illustrate the potential range of oxygen concentration available to the patient at a given tidal volume, supplemental oxygen ﬂow, and pressure setting. These figures represent bench test results without inadvertent mask leaks when oxygen is administered at the mask. Substantial leaks around the mask may reduce the expected oxygen concentration to below the levels shown in Figures 10-2 and 10-3. This guideline may be used as a starting point for initiating oxygen therapy. Oxygen ﬂow should be gradually adjusted until the patient’s oxygen needs are adequately met.

100

90 80 70 60 50

2 L/min

Supplemental O2 Flows:

10 L/min

10-3

15 L/min

Oxygen Concentration (%)

30 20 10

IPAP/EPAP Settings

600 cc Tidal Volume. Respiratory Rate: 20 BPM

Figure 10-2 Oxygen Concentration for 600cc Tidal Volume

Supplemental O

2 L/min

100

90 80 70 60 50 40

Flows:

10 L/min

30/520/510/5

15 L/min

Oxygen Concentration (%)

30 20 10

IPAP/EPAP Settings

1000 cc Tidal Volume. Respiratory Rate: 20 BPM

Figure 10-3 Oxygen Concentration for 1000cc Tidal Volume

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10-4

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Chapter 11: Cleaning and Maintenance

11.1 Cleaning the Synchrony

WARNING: To avoid electrical shock, always unplug the Synchrony power cord before cleaning the Synchrony.

CAUTION: Do not immerse the Synchrony in liquid or allow any liquid to enter the enclosure, inlet filter, or

any openings.

Unplug the Synchrony and clean the front panel and exterior of the enclosure as needed using a cloth dampened with water and a mild detergent. Allow the Synchrony to dry completely before plugging in the power cord.

The mask and tubing should be cleaned daily. For details on cleaning your mask and accessories, refer to the cleaning instructions packaged with the accessories.

11-1

CAUTION: Dirty inlet filters may cause high operating temperatures that may affect Synchrony performance.

Regularly examine the inlet filters as needed for integrity and cleanliness.

11.2 Cleaning or Replacing the Inlet Filters

The Synchrony uses two removable filters at the air inlet. The gray foam filter is washable and reusable. The optional white ultra-fine filter is disposable. The gray foam filer should be cleaned at least once every two weeks under normal usage and should be replaced with a new one every six months.

STEP 1 If the Synchrony is operating, stop the Synchrony by pressing the

STANDBY key. Disconnect the Synchrony from the power source.

STEP 2 Remove the filter cover by pressing down on the top of the cover to

release the tabs, then swinging the cover out from the Synchrony’s body.

STEP 3 Remove the filters from the enclosure. The top filter is the reusable

gray foam filter. The bottom filter is the optional disposable white ultra-fine filter.

STEP 4 Examine the filters regularly for cleanliness and integrity.

Reusable Pollen

Filter

Disposable Ultra-fine

Filter

STEP 5 If needed, wash the gray foam filter in warm water with a mild

detergent. Rinse thoroughly to remove all detergent residue. Allow the filter to completely dry before reinstalling it. If the foam filter is torn, replace it. (Only Respironics supplied filters should be used as replacement filters.)

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11-2

STEP 6 If the ultra-fine filter is dirty or torn, replace it. STEP 7 Reinstall the filters, with the ultra-fine filter on the bottom. Slide the filters into the air

inlet at the rear of the Synchrony and push them down into the recess.

CAUTION: Never install a wet filter into the Synchrony. We recommend that you clean the used filter in the

morning and alternate use of the two pollen filters provided with the system. This will allow enough drying time for the cleaned filter.

STEP 8 Reinstall the filter cover.

11.3 Maintenance

WARNING: Electrical cords or cables should be periodically inspected for damage or signs of wear.

See the Synchrony Service Manual for recommended periodic maintenance.

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Chapter 12: Circuits and Accessories

This chapter details the Respironics-approved breathing circuits and accessories.

WARNING: Refer to each accessory’s instruction sheets for the applicable warnings, cautions, and notes.

12.1 Circuit Configurations

WARNING: The Synchrony requires an intentional leak port, either built into the mask or on a separate exhalation

device (e.g., Whisper Swivel II, Plateau Exhalation Valve [PEV], or Disposable Exhalation Valve) to remove exhaled air from the circuit. Therefore, specific masks and circuits using an intentional leak port are required for normal operation. The pressurized air from the Synchrony causes a continuous flow of air to exhaust from the leak port to flush the exhaled air from the circuit. The Synchrony should be turned on and the intentional leak port should be checked before using the Synchrony.

12-1

The Synchrony is intended for use with Respironics-approved patient circuits. Typical components are:

• bacteria filter (optional)

• 22 mm reusable circuit tubing

• exhalation device

• Respironics patient interface (e.g., mask)

• humidifier (optional)

Additional accessories may be added to the circuit to meet specific needs.

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12-2

12.2 Circuits and Accessories

—Reusable or Disposable Circuit

Reusable smooth inner lumen circuit tubing, exhalation port. Disposable smooth inner lumen circuit tubing, exhalation port.

—Circuit Accessories:

6" disposable circuit tubing 18" disposable circuit tubing 72" disposable circuit tubing O2 enrichment attachment bacteria ﬁlter

—Synchrony Accessories:

oxygen valve DC power cord

12.3Masks, Exhalation Ports, and Related Accessories

—Masks:

Respironics mask with built-in exhalation port or Respironics mask with separate exhalation device.

—Accessories:

disposable headgear reusable headgear chin strap Comfort Flap® mask accessory

WARNING: The PEV option must be enabled if a Plateau Exhalation Valve (PEV) is used.

12.4Humidifiers

—Respironics Pass-over humidifier —Respironics H2 Heated Humidifier

12.5Software

Respironics Encore® and Encore Pro Data Management Software for reading compliance data.

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Chapter 13: Operational Verification

WARNING: If the Synchrony system fails to perform within the stated specifications of Chapter 14, have the system

serviced by a qualified Respironics-approved service facility.

NOTE: If the backlight is off, the first press of the , , or key will only turn the backlight on; the normal key

action is suppressed until the key is pressed a second time. All procedures assume the backlight is already on.

NOTE: This procedure does not verify performance of the optional Oxygen Valve. If this valve is installed and a

performance verification is required, refer to the Synchrony Service Manual.

NOTE: If the indicator does not move when you are simulating breaths, press the RAMP key to exit flow limit

control.

13-1

13.1 S Mode Verification

The operational verification allows the home care provider to verify that the Synchrony is functioning properly. Operational verification should be completed before each new patient setup.

STEP 1 Connect the patient circuit to the Synchrony as described in Chapter

4 of this manual.

STEP 2 Connect a water column or digital manometer to a mask port. STEP 3 Connect the AC inlet to the Synchrony and connect the AC line to

the appropriate power source. The AC power LED should be illuminated.

STEP 4 Press the Standby key to start the Synchrony. STEP 5 Set the parameters to the following:

• Mode = S

• Bi-Flex = OFF

• IPAP = 20 cm H2O

• EPAP = 4 cm H2O

• IPAP Rise Time = 1

• Patient Disconnect Alarm Delay = OFF

• Apnea = OFF

• LowMinVent = OFF

STEP 6 Simulate a breathing pattern by occluding and opening the patient

outlet.

• Verify that the indicator appears next to the “IPAP” display during the inspiratory phase and appears next to the “EPAP” display during the expiratory phase.

• Verify the IPAP and EPAP pressures displayed on the Synchrony screen agree with the pressures indicated on the manometer.

If you wish to verify the performance of the patient alarms, see Section 13.3.

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13-2

13.2 S/T Mode Verification

STEP 1 Connect the patient circuit to the Synchrony as described in Chapter

4 of this manual.

STEP 2 Connect a water column or digital manometer to a mask port. STEP 3 Connect the AC inlet to the Synchrony and connect the AC line to

the appropriate power source. The AC power LED should be illuminated.

STEP 4 Press the Standby key to start the Synchrony. STEP 5 Set the parameters to the following:

• Mode = S/T

• IPAP = 20 cm H2O

• EPAP = 4 cm H2O

• Rate = 6 BPM

• Timed Inspiration = 1.5 sec

• IPAP Rise Time = 1

• Patient Disconnect Alarm Delay = OFF

• Apnea = OFF

• LowMinVent = OFF

STEP 6 Simulate a breathing pattern by occluding and opening the patient

outlet.

• Verify that the indicator appears next to the “IPAP” display during the inspiratory phase and appears next to the “EPAP” display during the expiratory phase.

STEP 7 When you have established an IPAP/EPAP pattern, occlude the

patient circuit.

STEP 8 Wait for the Synchrony to establish a breathing pattern according to

the settings of Step 5.

• Verify that the indicator appears next to the ”Rate” display when the Synchrony initiates a breath.

• Verify the IPAP and EPAP pressures displayed on the Synchrony screen agree with the pressures indicated on the manometer.

If you wish to verify the performance of the patient alarms, see Section 13.3.

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13-3

13.3 Alarm Verification

STEP 1 Keep the patient circuit and parameter setups as used in the S or S/T

verification.

STEP 2 Set the Patient Disconnect Alarm Delay to 15 sec. STEP 3 Exit to the Monitoring screen. Open the patient circuit to

atmosphere.

• Verify that the Patient Disconnect Alarm occurs in 15 seconds.

STEP 4 Press the RAMP key to silence the alarm. Then clear the alarm

screen using the ENTER key. Next simulate a breathing pattern by occluding and opening the patient outlet to correct the alarm condition.

NOTE: The red high priority alarm indicator light will appear solid when the

alarm condition has subsided. It will take several breaths to correct the alarm condition. The light will remain solid until the alarm has been cleared.

STEP 5 Set the following alarms:

• Patient Disconnect Alarm = OFF

• Apnea = 10 sec

STEP 6 Exit to the Monitoring screen. To ensure that Flow Limit Control is

not active, simulate a breathing pattern until the IPAP/EPAP activity indicator ( ) moves; then occlude the patient outlet.

• Verify that the Apnea Alarm occurs in 10 seconds.

STEP 7 Clear the alarm; set the following alarms:

• Apnea = OFF

• LowMinVent = 20 L/min

STEP 8 Exit to Monitoring screen 2 (to display Minute Ventilation). STEP 9 Simulate 6 breaths by alternately occluding and opening the patient

outlet.

STEP 10 After 6 breaths, alter the breathing pattern to lower the minute

ventilation below the alarm setpoint of 20 L/min.

• Verify that the LowMinVent alarm occurs.

STEP 11 Clear the alarm. STEP 12 While the Synchrony is still operating, disconnect the power cord

from the Synchrony.

• Verify that a continuous alarm sounds for at least two minutes.

Adjust the Synchrony to the appropriate patient settings after the Performance Verification and before patient use.

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13-4

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Chapter 14: Speciﬁcations

ENVIRONMENT AL

14-1

PHYSICAL

ELECTRICAL

Temperature Humidity

Atmospheric Pressure

Dimensions:

Weight:

AC Voltage:

DC Voltage:

AC Current:

12" L x 7" W x 6" H

Approximately 6 lb

100 to 240 V , 50/60 Hz

12 V

1.25 A maximum

Operating

41 °F to 95 °F

15 to 95% Relative

(non-condensing)

83 to 102 kPa

(5600 feet to sea level)

Storage

-4 °F to 140 °F

15 to 95% Relative

(non-condensing)

50 kPa to 106 kPa

(20000 feet to sea level)

DC Current:

Protection against electric shock:

Degree of protection against

electric shock:

Degree of protection against

harmful ingress of water:

Modes of Operation:

Electromagnetic

Compatibility:

PRESSURE

5.5 A maximum

Class II

Type BF Applied Part

Ordinary Equipment, IPX0

Continuous

The BiPAP Synchrony Ventilatory Support System meets the requirements of EN 60601-1-2.

Fuses:

Output: 4 to 30 cm H2O

There are no user-replaceable fuses.

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14-2

Specifications

CONTROL ACCURACY

Parameter Range Accuracy

IPAP 4 to 30 cm H2O** ± 2 cm H2O* EPAP 4 to 25 cm H2O** ± 2 cm H2O* CPAP 4 to 20 cm H2O ± 2 cm H2O* Breath Rate 0 to 30 BPM (PA and S/T); Greater of 1 BPM or ± 10% of setting when

4 to 30 BPM (T) measured over a four minute period.

Timed Inspiration 0.5 to 3.0 sec ± (0.1 + 0.10 of setting) sec Rise Time 1 to 6 ± 25%* Ventilation Ramp Disabled, 0.5, 1.0, 2.0, 3.0 cm H2O per breath ± (0.1 + 0.25 of setting) cm H2O/breath.

Measured over the full duration of the programmed ramp.

* Measured at the patient end of circuit with a Whisper Swivel II exhalation port and no patient flow. Dynamic pressure accuracy is ± 5 cm H2O measured at the patient end of the circuit with a Whisper Swivel II and varying flow conditions. The range of values correspond to hundreds of milliseconds (e.g., a setting of 4 indicates a Rise Time of .4 seconds).

* Limited to 4 to 20 cm H2O for IPAP/EPAP when Bi-Flex is enabled.

TRIGGER

Spontaneous

Trigger:

Spontaneous

Cycle:

—Shape Trigger —Volume 6 cc above V

—Spontaneous Expiratory Threshold (SET) —Shape Cycle —IPAP maximum of 3.0 sec —Flow Reversal - A flow reversal event causes the machine to cycle to EPAP

leak

ACCURACY OF MEASURED AND CALCULATED PARAMETERS

PARAMETER

Respiratory Rate

Exhaled Tidal Volume

Exhaled Minute Ventilation

Greater of ±1 BPM or ±10% of reading when measured over a four minute period

± (25 + 0.15 of reading) ml ± (1 + 0.15 of reading) L/min

ACCURACY

Leak Rate

CONNECTOR

The patient interface port is a 22 mm tapered connector.

± (5 + 0.15 of reading) L/min

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Pressure Drop Versus Flow for Patient Circuits

The Synchrony automatically compensates for pressure drops associated with a 6-foot smooth bore tube. Additional pressure drop will occur when restrictive elements are added to the patient circuit. The following graph shows the additional pressure drop when adding: 1. a bacteria filter; 2. a bacteria filter and a Respironics pass-over humidifier.

Note: Always use a manometer to verify patient mask pressure.

Pressure Drop VersusFlow for Patient Circuits

Bacteria Filter Bacterial Filter and Oasis Humidifier

9 8 7 6 5 4 3 2 1 0

0 20 40 60 80 100 120 140 160 180

Flow LPM

14-3

Maximum Pressure Drop for Patient Disconnect Alarm

The Patient Disconnect alarm relies on a fixed relationship between the patient pressure settings and the open circuit flow of the patient circuit. The alarm should work properly if your circuit is less restrictive than the circuit parameters shown below.

Most Restrictive Circuit for Patient Disconnect

180.00

160.00

140.00

120.00

100.00

80.00

60.00

40.00

20.00

0.00

NOTE: You must verify that the Patient Disconnect Alarm operates properly with the prescribed patient pressures

and circuit.

Pressure

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14-4

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Appendix A: External Modem Requirements

This chapter explains requirements for using an external modem with the Synchrony.

A-1

A.1 Serial Cable

The Synchrony is equipped with a 9-pin RS-232 port. The serial cable for connecting the external modem to the Synchrony must be a DTE-to-DCE cable (i.e., “straight-through” cable). This is the serial cable that normally comes with a modem, however, a diagram is shown in Figure A-1 for verification.

1 2 3 4 5 6 7 8 9

Figure A-1 Serial Cable Requirements

DCD

DTR

GND

DSR

RTS

CTS

1 2 3 4 5 6 7 8 9

A.2 Modem Commands

The Synchrony makes the following assumptions regarding modem commands:

• The modem must be Hayes compatible and recognize the AT command set.

• The ATZ[CR] command will reset the modem, where [CR] represents a carriage return (ASCII 13).

• The ATH0[CR] command will hang up the modem.

• The escape code sequence is a one-second guard time where no data is sent to the modem followed by the +++ command.

The Synchrony software uses the DTR line on the RS-232 port to aid in hanging up the modem. It is strongly recommended that the external modem be configured to monitor the DTR line. Normally, this is the default operation for the modem. If it is not, you should add the &D2 option in the modem initialization string.

The Synchrony software requires that modem commands and modem result codes are echoed back to the Synchrony. Normally, this is the default operation for the modem. If not, you should add the E1, X4, AND Q0 options in the modem initialization string.

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A-2

The Synchrony software handles both numerical (short-form) and verbose (long-form) result codes. However, it will only recognize the verbose result codes that contain the following words in English: OK, ERROR, CONNECT,

RING, NO CARRIER, NO DIALTONE, NO DIAL TONE, BUSY, NO ANSWER. Normally, the default option for the modem verbose result codes,

which is typically configured with the V1 option. If not, the V0 option specifies numerical result codes. In either case, it is recommended that you specify this option in the initialization string.

The Synchrony software currently does not handle the answering of incoming calls. Therefore, you should configure the modem by setting the S0 register to zero (i.e., S0=0 in the initialization string).

A.3 Example

Initialization Strings

The Synchrony requires that you specify two initialization strings. The following recommendations work with U.S. Robotics modems and should work with others:

• Init String 1: AT&FX4V1E1Q0D2

• Init String 2: ATS0=0

To turn off the modem’s speaker, add the M0 option. The initialization strings would appear as follows:

• Init String 1: AT&FX4V1E1Q0D2

• Init String 2: ATM0S0=0

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Appendix B: Error Codes

This appendix lists the definitions for the displayed error codes (see Section 7.2.2)

B-1

ERROR DEFINITION CODE

1 ERR_SOFTWARE 2 CPU_FAILURE 3 STACK_OVERFLOW_FAILURE 4 STACK_UNDERFLOW_FAILURE 5 STACK_RESERVE_FAILURE 6 RAM_FAILURE 7 STUCK_KEY_FAILURE 8 CORRUPT_RX_MODE_FAILURE 9 CORRUPT_RX_PARM_IN_MODE_FAILURE 10 CORRUPT_RX_PARM_OUT_MODE_FAILURE 11 CORRUPT_ALARM_PARM_FAILURE 12 CORRUPT_SYSTEM_DATA_FAILURE 13 CORRUPT_MODEM_PARM_FAILURE 14 CORRUPT_USAGE_LOG_DATA_FAILURE 15 CORRUPT_SW_VERSION_DATA_FAILURE 16 SOFTWARE_CHANGE_FAILURE 17 DATA_FLASH_ERASE_FAILURE 18 DATA_FLASH_WRITE_FAILURE 19 DATA_FLASH_OVERLAP_PAGE_1_FAILURE 20 DATA_FLASH_OVERLAP_PAGE_2_FAILURE 21 DATA_FLASH_OVERLAP_PAGE_3_FAILURE 22 DATA_FLASH_OVERLAP_PAGE_4_FAILURE 23 BUZZER_SOUND_FAILURE 24 LCD_CUST_CHAR_FAILURE 25 RED_ALARM_LED_FAILURE 26 YELLOW_ALARM_LED_FAILURE 27 GREEN_DC_POWER_LED_FAILURE 28 GREEN_AC_POWER_LED_FAILURE 29 RTC_NOT_TICKING_FAILURE 30 RTC_BATTERY_LOW_FAILURE 31 RTC_DATA_CORRUPT_FAILURE 32 WATCHDOG_FAILURE 33 GET_THERAPY_LOG_DATA_ERR1 34 BREAKPOINT_EXCEPTION_FAILURE 35 BUS_ERROR_EXCEPTION_FAILURE 36 SOFTWARE_INTERRUPT_FAILURE 37 ILLEGAL_INSTRUCT_EXCEPT_FAILURE, 38 DIVIDE_BY_ZERO_EXCEPTION_FAILURE 39 UNUSED_INTERRUPT_FAILURE 40 UNINIT_INTERRUPT_FAILURE 41 SPURIOUS_INT_EXCEPTION_FAILURE 42 HIGH_PRIORITY_THREAD_INACTIVE 43 LOW_PRIORITY_THREAD_INACTIVE 44 BACKGROUND_THREAD_INACTIVE 45 FRONT_PANEL_TEST_NO_KEY_FAILURE 46 FRONT_PANEL_TEST_UP_KEY_FAILURE 47 FRONT_PANEL_TEST_DOWN_KEY_FAILURE 48 FRONT_PANEL_TEST_ENTER_KEY_FAILURE 49 FRONT_PANEL_TEST_RAMP_KEY_FAILURE 50 FRONT_PANEL_TEST_SECRET_KEY_FAILURE 51 LCD_DISPLAY_CTRL_TIMEOUT 52 LCD_DISPLAY_DATA_TIMEOUT 53 LCD_DISPLAY_READ_TIMEOUT 54 ADC_CONVERSION_FAILURE 55 SYS_DATA_BAD_RANGE_FAILURE 56 LOSS_AC_OPER_DC_POWER 57 MOMENTARY_LOSS_OF_POWER 58 BATTERY_IN_USE_ALARM 59 LOW_BATTERY_ALARM

ERROR DEFINITION CODE

60 BATTERY_FAILURE_ALARM 61 HIGH_BATTERY_ALARM 62 LOW_MIN_VENT_ALARM 63 EXHALATION_PORT_ALARM 64 APNEA_ALARM 65 PATIENT_DISCONNECT_ALARM 66 HIGH_PRESSURE_ALARM 67 LOW_PRESSURE_ALARM 68 PROX_LINE_ALARM 69 WAIT_FOR_TRIG_ERR1 70 COMPUTE_MINVENT_ERR1 71 COMPUTE_PERCENT_TI_ERR1 72 COMPUTE_BPM_ERR1 73 COMPUTE_PAT_TRIG_BREATHS_ERR1 74 COMPUTE_TIME_AT_P_ERR1 75 COMPUTE_TIME_AT_P_ERR2 76 GET_CALC_PARAM_ERR1 77 ROM_CRC_FAILURE 78 VREF_12000_FAILURE 79 AUDIBLE_ALARM_VCAP_FAILURE 80 FRONT_PANEL_TEST_STANDBY_KEY_FAILURE 81 UI_ALARM_QUEUE_FULL_FAILURE 82 CAL_DATA_CRC_FAILURE 83 AIR_STREAM_OVER_TEMP 84 AIR_STREAM_UNDER_TEMP 85 AUDIBLE_ALARM_VOLTAGE_FAILURE 86 MOTOR_FAILURE 87 DEFAULT_SWITCH_MODEM_HANGUP 88 DEFAULT_SWITCH_MODEM_INIT 89 EXECUTION_SEQUENCE_FAILURE 90 DEFAULT_SWITCH_MODEM_REGAINCONTROL 91 RESICALC_UNIT_ID 92 DEFAULT_SWITCH_MODEM_ESCAPE_SEQ 93 CORRUPT_KNOWN_LEAK_DATA 94 DEFAULT_SWITCH_MODEM_PROCESS_CMD 95 BARO_PRESSURE_FAILURE 96 BAD_RESISTANCE_TABLE 97 DRIFT_TOO_HIGH 98 DRIFT_HIGH 99 DRIFT_CRC_FAILURE 100 MAX_RESETS_OVER_TIME 101 CORRUPT_ACCESS_KEY_DATA_FAILURE 102 CORRUPT_TLOG_STORAGE_DATA_FAILURE 103 INVALID_TEST_CALL 104 UNRECOGNIZED_BOARD_REVISION_BY_SW 105 BLOWER_ERROR_SIGNAL_FAILED 106 BLOWER_CURRENT_FAILED_HIGH 107 BLOWER_CURRENT_FAILED_LOW 108 BLOWER_RPM_FAILED_HIGH, 109 BLOWER_RPM_FAILED_LOW 110 VALVE_ENABLE_FAILURE 111 VREF_1250_FAILURE 112 COMPUTE_AVG_LEAK_ERR1 113 BACKGROUND_THREAD_DEFAULT_SWITCH 114 COPY_FLASH_FUNCTIONS_FAILURE 115 UI_EVENT_QUEUE_FULL_FAILURE 116 RISE_RATE_RANGE_FAILURE 117 PRESSURE_RANGE_FAILURE 118 IRFLOW_STUCK_SENSOR

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B-2

ERROR DEFINITION CODE

119 PATM_STUCK_SENSOR 120 PP_STUCK_SENSOR 121 PV1_STUCK_SENSOR 122 PV2_STUCK_SENSOR 123 ERASE_SECTOR_FAIL 124 WRITE_FLASH_FAIL 125 UNRECOGNIZED_ACCESS_KEY_VERSION 126 PV1_PV2_SENSOR_FAILURE 127 DATA_LOGGING_ERR1 128 SCAN_EVENTS_ERR 129 LOG_INITIAL_VALUES_ERR1 130 LOG_EVENT_ERR1 131 DATA_FLASH_ERR 132 SYS_PT_ALARM_LOG_CHECKSUM_ERR 133 CORRUPT_SYS_ALARM_LOG_DATA_FAILURE 134 CORRUPT_PT_ALARM_LOG_DATA_FAILURE 135 BLOWER_DEFAULT_ERR1 136 BLOWER_OFF_CURRENT_HIGH 137 UNRECOGNIZED_CAL_VERSION_BY_SW 138 UNIT_TYPE_FAILURE 139 TLOG_WRITE_QUEUE_BAD_DATA 140 UNEXPECTED_WATCHDOG_RESET 141 VALVE_DEFAULT_ERR1 142 DRIFT_DEFAULT_ERR1 143 UI_HIGH_PRIORITY_ALARM_TEST 144 UI_2_HIGH_PRIORITY_ALARM_TEST 145 UI_MEDIUM_PRIORITY_ALARM_TEST 146 UI_2_MEDIUM_PRIORITY_ALARM_TEST 147 UI_LOW_PRIORITY_ALARM_TEST 148 UI_2_LOW_PRIORITY_ALARM_TEST 149 LOW_PRESSURE_SUPPORT_ALARM 150 INVALID_DRIFT_INDEX_AT_CAL 151 INVALID_TCAL_AT_CAL 152 INVALID_MODE_IN_CURRENT_MODEL 153 UNSUPPORTED_FEATURE_SET 154 LOW_TIDAL_VOLUME_ALARM 155 VTE_TARGET_SETPOINT_ZERO 156 ERR_BRMODEL_MAX_AMPLITUDE 157 ERR_RAMP_DEFAULT1 158 INVALID_ALARM_CODE

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Index

I-1

Abbreviations 2-10 AC Inlet 3-8 AC Operation 4-4 AC Power Indicator 3-2 Access Levels 2-8

Changing 7-10

Unlocking 7-10 Accessories 12-2 Accuracy Specifications 14-2 Acronyms 2-10 Air Filters

Cover 3-8

Installation 4-2 Alarm

Actions During 8-8

Defintions 8-12

Description 8-1

Display 8-6

High Priority 8-9

History 7-4

LEDs 8-7

Low Priority 8-11

Medium Priority 8-10

Sounds 8-6

Tables 8-9 Alarm Enabled Indicator 3-5 Alarm Parameters

Apnea 8-4

Changing 8-3

Patient Disconnect Alarm Delay 8-3

Setting 8-2 Alarm Volume 7-12 Apnea Alarm 8-4

Changing 8-5 Assembling the Patient Circuit 4-3 Attention or Activity Indicator 3-3 Auto-Trak Sensitivity 2-4

backlight 3-1 Bi-Flex 2-2 BiPAP Defined 2-10

Cable A-1 Cautions 1-3 Change Mode Operations 6-1 Change Mode Setup Screens 6-2 Change Parameters Operations 5-1

Change Parameters Screens 5-2 Changing

Access Level 7-10 Alarm Volume 7-12 Language 7-11 Mode 6-3 Parameters 5-4

Circuit Configurations

Patient 12-1

Cleaning

Filters 11-1

Synchrony 11-1 Codes, System 7-3 Commands

Modem A-1 Communication Statements 1-5 Communications 9-1

Encore Software 9-1

Optional Modem 9-1

Port 3-8 Concentrations of Oxygen 10-3 Connecting the Patient 4-5 Connections

AC Inlet 3-8

Communications Port 3-8

DC Inlet 3-8

Patient Circuit 3-7

RS232 Port 3-8

Telephone Jack 3-8 Contraindications 1-4 Control Keys 3-2

Down Key 3-2

Enter Key 3-2

Ramp/Silence Key 3-2

Standby Key 3-2

Up Key 3-2 Control Panel 3-1 Controls and Displays 3-1

AC Power Indicator 3-2

Attention or Activity Indicator 3-3

Control Keys 3-2

Control Panel 3-1

DC Power Indicator 3-2

Display Data 3-6

Display Screen 3-1

Down Key 3-2

Enter Key 3-2

Indicators 3-2

Navigation Indicator 3-4

Progress Indicator 3-5

Ramp/Silence Key 3-2

Rear Panel 3-8

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I-2

Selection Indicator 3-4 Standby Key 3-2 Up Key 3-2 Ventilation Ramp Indicator 3-4

CPAP

Defined 2-10 Mode 2-2 Mode Parameter Screen 5-2

Mode Setup Screen 6-2 Cycle Defined 2-10 Cycle to EPAP 2-7

Data Transmission Errors 4-9 DC Inlet 3-8 DC Operation 4-4 DC Power Cord Retainer 3-8 DC Power Indicator 3-2 Definitions 2-10

Alarm 8-12

Bi-Flex 2-9

BiPAP 2-10

CPAP 2-10

Cycle 2-10

EPAP 2-10

High Priority Alarm 2-10

IPAP 2-10

Low Priority Alarm 2-10

Medium Priority Alarm 2-10

OSA 2-10

Ramp 2-10

Trigger 2-10 Description

Alarms 8-1 Design

Flow Analysis 2-8

Maximum IPAP Time 2-7

Sensitivity 2-5

Shape Signal 2-6

Spontaneous Expiratory Threshold 2-7

Volume Trigger 2-6 Dialing the Provider 4-8 Display

Alarm 8-6 Display Data 3-6 Down Key 3-2

Electrical

AC Operation 4-4

DC Operation 4-4 Electrical Specifications 14-1 Encore 2-1, 9-1 Enter Key 3-2 Environmental Specifications 14-1 EPAP Defined 2-10

Errors

Data Transmission 4-9 Estimated Exhaled Minute Ventilation 3-6 Estimated Exhaled Tidal Volume 3-6 Example Initialization Strings

Modem A-2 Expiratory Flow Rate Adjustment 2-4 External Modem Requirements A-1

Filters, Replacing/Cleaning 11-1 Flow Analysis 2-8 Flow Reversal 2-7 Full Access 2-8

High Priority Alarms

Actions 8-9

Defined 2-10 Humidifiers 12-2

Indicators 3-2

AC Power Indicator 3-2

Alarm Enabled Indicator 3-5

Attention or Activity Indicator 3-3

DC Power Indicator 3-2

Navigation Indicator 3-4

Progress Indicator 3-5

Selection Indicator 3-4

Ventilation Ramp Indicator 3-4 Industry of Canada Notice 1-6 Initialization Strings

Modem A-2 Installing the Air Filters 4-2 Intended Use 1-4 Introduction 2-1 IPAP Defined 2-10

Lab System 2-1, 2-2, 4-5, 5-1, 6-1 Language 7-11 Leak 3-6 Leak Tolerance 2-4 LEDs

Alarm 8-7 Lockout 2-8 Low Priority Alarms

Actions 8-11

Defined 2-10

Maintenance 11-1 Masks, Exhalation Ports 12-2 Maximum IPAP Time 2-7

Provider Manua